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Full text of "North Carolina Register v.8 no. 12 (9/15/1993)"

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RECEIVED 

'SEP i^ 1993 
LAW LIBRARY 



NORTH CAROLINA 



{± 



REGISTER 



IN TfflS ISSUE 



EXECUTIVE ORDER 



ITJTM 

hriow 



y 



PROPOSED RULES 
Administration 

Environment, Health, and Natural Resources 
Human Resources 
Insurance 
Justice 

Refrigeration Examiners 
State Treasurer 
Transportation 



RRC OBJECTIONS 



RULES INVALIDATED BY JUDICIAL DECISION 



CONTESTED CASE DECISIONS 



ISSUE DATE: September 15, 1993 
Volume 8 • Issue 12 • Pages 1007 - 1184 



INFORMATION ABOUT THE NORTH CAROLINA REGISTER AND ADMTNTSTRATTVE CODE 



NORTH CAROLINA REGISTER 



TEMPORARY RULES 



The North Carolina Register is published twice a month and 
contains information relating to agency, executive, legislative and 
judicial actions required by or affecting Chapter 150B of the 
Genera] Statutes. All proposed administrative rules and notices of 
public hearings filed under G.S. 150B-21.2 must be published in 
the Register. The Register will typically comprise approximately 
fifty pages per issue of legal text. 

State law requires that a copy of each issue be provided free of 
charge to each county in the state and to various state officials and 
institutions. 

The North Carolina Register is available by yearly subscription 
at a cost of one hundred and five dollars (S105.00) for 24 issues. 
Individual issues may be purchased for eight dollars (S8.00). 

Requests for subscription to the North Carolina Register should 
be directed to the Office of Administrative Hearings, 
P. 0. Drawer 27447, Raleigh, N. C. 2761 1-7447. 



Under certain emergency conditions, agencies may issue 
temporary rules. Within 24 hours of submission to OAH, the 
Codifier of Rules must review the agency's written statement of 
findings of need for the temporary rule pursuant to the provisions in 
G.S. 150B-21.1. If the Codifier determines that the findings meet 
the criteria in G.S. 150B-21.1, the rule is entered into the NCAC. If 
the Codifier determines that the fmdings do not meet the criteria, 
the rule is returned to the agency. The agency may supplement its 
findings and resubmit the temporary rule for an additional review 
or the agency may respond that it will remain with its initial 
position. The Codifier, thereafter, will enter the rule into the 
NCAC. A temporary rule becomes effective either when the 
Codifier of Rules enters the rule in the Code or on the sixth 
business day after the agency resubmits the rule without change. 
The temporary rule is in effect for the period specified in the rule or 
180 days, whichever is less. An agency adopting a temporary rule 
must begin rule-making procedures on the permanent rule at the 
same time the temporary rule is filed with the Codifier. 



ADOPTION AMENDMENT, AND REPEAL OF 
RULES 



NORTH CAROLINA ADMINISTRATIVE CODE 



TTie following is a generalized statement of the procedures to be 
followed for an agency to adopt, amend, or repeal a rule. For the 
specific statutory authority, please consult Article 2A of Chapter 
150B of the General Statutes. 

Any agency intending to adopt, amend, or repeal a rule must 
first publish notice of the proposed action in the North Carolina 
Register. The notice must include the time and place of the public 
hearing (or instructions on how a member of the public may request 
a hearing); a statement of procedure for public comments; the text 
of the proposed rule or the statement of subject matter; the reason 
for the proposed action; a reference to the statutory authority for the 
action and the proposed effective date. 

Unless a specific statute provides otherwise, at least 15 days 
must elapse following publication of the notice in the North 
Carolina Register before the agency may conduct the public 
hearing and at least 30 days must elapse before the agency can take 
action on the proposed rule. An agency may not adopt a rule that 
differs substantially from the proposed form published as part of 
the public notice, until the adopted version has been published in 
the North Carolina Register for an additional 30 day comment 
period. 

When final action is taken, the promulgating agency must file 
the rule with the Rules Review Commission (RRC). After approval 
by RRC, the adopted rule is filed with the Office of Administrative 
Hearmgs (OAH). 

A rule or amended rule generally becomes effective 5 business 
days after the rule is filed with the Office of Administrative 
Hearings for publication in the North Carolina Administrative Code 
(NCAC). 

Proposed action on rules may be withdrawn by the promulgatmg 
agency at any time before final action is taken by the agency or 
before filing with OAH for publication in the NCAC. 



The North Carolina Administrative Code (NCAC) is a 
compilation and index of the administrative rules of 25 state 
agencies and 38 occupational licensing boards. The NCAC 
comprises approximately 15,000 letter size, single spaced pages of 
material of which approximately 35% of is changed annually. 
Compilation and publication of the NCAC is mandated bv G.S. 
150B-21.18. 

The Code is divided into Titles and Chapters. Each state agency 
is assigned a separate title which is further broken down by 
chapters. Title 21 is designated for occupational licensing boards. 

The NCAC is available in two formats. 

(1) Single pages may be obtained at a minimum cost of 
two dollars and 50 cents (S2.50) for 10 pages or less, 
plus fifteen cents (50.15) per each additional page. 

(2) The full publication consists of 53 volumes, totaling in 
excess of 15.000 pages. It is supplemented monthly 
with replacement pages. A one year subscription to the 
full publication including supplements can be 
purchased for seven hundred and fifty dollars 
(S750.00). Individual volumes may also be purchased 
with supplement service. Renewal subscriptions for 
supplements to the initial publication are available. 

Requests for pages of rules or volumes of the NCAC should be 
directed to the Office of Administrative Hearings. 



CITATION TO THE NORTH CAROLINA 
REGISTER 

The North Carolina Register is cited by volume, issue, page 
number and date. 1:1 NCR 101-201, April 1, 1986 refers to 
Volume 1, Issue 1, pages 101 through 201 of the North Carolina 
Register issued on April 1, 1985. 



FOR INFORMATION CONTACT: Office of 
■Administrative Hearings. ATTN: Rules Division, P.O. 
Drawer 27447, Raleigh. North Carolina 27611-7447, (919) 
733-2678. 



NORTH 
CAROLINA 
REGISTER 




Office of Administrative Hearings 

P. O. Drawer 27447 

Raleigh, North Carolina 27611-7447 

(919) 733-2678 



Julian Mann III, 

Director 
James R. Scarcella Sr., 

Deputy Director 
Molly Masich, 

Director ofAPA Services 



Staff: 

Ruby Creech, 

Publications Coordinator 
Teresa Kilpatrick, 

Editorial Assistant 
Jean Shirley, 

Editorial Assistant 



ISSUE CONTENTS 

I. EXECUTIVE ORDER 

Executive Order 23 1007 

11. PROPOSED RULES 
Administration 

State Employees Combined 

Campaign 1008 

Environment, Health, and 

Natural Resources 

Health Services 1098 

Human Resources 

Facility Services 1014 

Mental Health, Developmental 
Disabilities and Substance Abuse 
Services 1086 

Social Services 1091 

Insurance 

Financial Evaluation Division . . . 1093 

Life and Health Division 1094 

Special Services Division 1096 

Justice 

Departmental Rules 1096 

Licensing Board 

Refrigeration Examiners 1148 

State Treasurer 

Retirement System 1146 

Transportation 

Motor Vehicles, Division of ... . 1145 

III. RRC OBJECTIONS 1151 

IV. RULES INVALIDATED BY 
JUDICIAL DECISION 1155 

V. CONTESTED CASE DECISIONS 

Index to ALJ Decisions 1156 

Text of Selected Decisions 

92 OSP 1606 1163 

93 HRC 0167 11^ 

93 CPS0205 1171 

93 EHR0276 1176 

VI. CUMULATIVE INDEX 1182 



NORTH CAROLINA REGISTER 

Publication Schedule 

(July 1993 - May 1994) 



Volume 

and 

Issue 

Number 


Issue 
Date 


Last Day 

for 

Filing 


Last Day 

for Elec- 

tromc 

Filmg 


Earliest 

Date for 

PubUc 

Hearing 

15 days 

from 

notice 


* End of 

Required 

Comment 

Penod 

30 days 

from 

notice 


Iflst Day 

to Submit 

to RRC 


** Earliest 

Effective 

Date 


8:7 


07/01/93 


06/10/93 


06/17/93 


07/16/93 


08/02/93 


08/20/93 


10/01/93 


8:8 


07/15/93 


06/23/93 


06/30/93 


07/30/93 


08/16/93 


08/20/93 


10/01/93 


8:9 


08/02/93 


07/12/93 


07/19/93 


08/17/93 


09/01/93 


09/20/93 


11/01/93 


8:10 


08/16/93 


07/26/93 


08/02/93 


08/31/93 


09/15/93 


09/20/93 


11/01/93 


8:11 


09/01/93 


08/11/93 


08/18/93 


09/16/93 


10/01/93 


10/20/93 


12/01/93 


8:12 


09/15/93 


08/24/93 


08/31/93 


09/30/93 


10/15/93 


10/20/93 


12/01/93 


8:13 


10/01/93 


09/10/93 


09/17/93 


10/18/93 


11/01/93 


11/22/93 


01/04/94 


8:14 


10/15/93 


09/24/93 


10/01/93 


11/01/93 


11/15/93 


11/22/93 


01/04/94 


8:15 


11/01/93 


10/11/93 


10/18/93 


11/16/93 


12/01/93 


12/20/93 


02/01/94 


8:16 


11/15/93 


10/22/93 


10/29/93 


11/30/93 


12/15/93 


12/20/93 


02/01/94 


8:17 


12/01/93 


11/05/93 


11/15/93 


12/16/93 


01/03/94 


01/20/94 


03/01/94 


8:18 


12/15/93 


11/24/93 


12/01/93 


12/30/93 


01/14/94 


01/20/94 


03/01/94 


8:19 


01/03/94 


12/08 '93 


12/15/93 


01/18/94 


02/02/94 


02/21/94 


04/01/94 


8:20 


01/14/94 


12/21/93 


12/30/93 


01/31/94 


02/14/94 


02/21/94 


04/01/94 


8:21 


02/01/94 


01/10/94 


01/18/94 


02/16/94 


03/03/94 


03/21/94 


05/01/94 


8:22 


02/15/94 


01/25/94 


02/10/94 


03/02/94 


03/17/94 


03/21/94 


05/01/94 


8:23 


03/01/94 


02/08/94 


02/15/94 


03/16/94 


03/31/94 


04/20/94 


06/01/94 


8:24 


03/15/94 


02/22/94 


03/10/94 


03/30/94 


04/14/94 


04/20/94 


06/01/94 


9:1 


04/04/94 


03/11/94 


03/18/94 


04/19/94 


05/04/94 


05/20/94 


07/01/94 


9:2 


04/15/94 


03/24/94 


03/31/94 


05/02/94 


05/16/94 


05/20/94 


07/01/94 


9:3 


05/02/94 


04/11/94 


04/18/94 


05/17/94 


06/01/94 


06/20/94 


08/01/94 


9:4 


05/16/94 


04/25/94 


05/02/94 


05/31/94 


06/15/94 


06/20'94 


08/01/94 



Note: Time is computed according to the Rules of Civil Procedure, Rule 6. 

* An agency must accept comments for at least 30 days after the proposed text is published or until the date 
of any public hearing, whichever is longer. See G.S. 150B-21. 2(f) for adoption procedures. 

** The "Earliest Effective Date " is computed assuming that the agency follows the publication schedule above, 
that the Rules Re\ie^v Commission approves the rule at the next calendar month meeting after submission, and 
that RRC delivers the rule to the Codifier of Rules five (5j business days before the 1st business day of the next 
calendar month. 



Rexised 07/93 



EXECUTIVE ORDER 



EXECUTIVE ORDER NUMBER 23 

PUBLIC SCHOOL ADMINISTRATOR 

TASK FORCE 

WHEREAS, this Administration has a goal of 
doing more with less in our public schools by 
increasing effectiveness and efficiency; 

WHEREAS, business and industry leaders have 
built up valuable expertise in using this strategy; 

WHEREAS, the most effective and efficient ratio 
of local public school administrators to teachers 
and students is not icnown; 

NOW, THEREFORE, by the power vested in me 
as Governor by the Constitution and laws of North 
Carolina, IT IS ORDERED: 



Section 1. Recission of Executive Order. 

Executive Order 12, dated May 12, 1993, 
hereby rescinded. 



IS 



(b) 



Section 2. Establishment. 

There is hereby established a Public School 
Administrator Task Force ("Task Force"). 

Section 3. Membership and Chair. 

The Task Force shall consist of the following 

members: 

(a) twelve business and industry leaders with 

experience in improving effectiveness and 

efficiency in their organizations appointed 

by the Governor; 

nine representatives of the public school 
system, appointed by the Governor, 
consisting of: three superintendents, 
three principals, and three teachers. A 
small, medium, and large public school 
system shall be represented in each cate- 
gory; 

the Director of State Personnel, or his 
designee; 

the State Auditor, or his designee; 
the Superintendent of Public Instruction, 
or his designee; and 
the State Budget Officer, or his designee. 



(c) 

(d) 
(e) 

(f) 



school administrators to teachers and 
students; 

(b) Determine the ratio necessary to effec- 
tively and efficiently administer quality 
education at the local level; 

(c) Develop guidelines for local public 
school administrators to follow in imple- 
menting more effective and efficient 
administration; and 

(d) Report its findings and recommendations 
to the Joint Legislative Education Over- 
sight Committee and to the State Board 
of Education by May 1, 1994. 

Section 5. Administration and Expenses. 

The Task Force members shall be reimbursed for 
reasonable travel and other expenses as allowed by 
North Carolina law. Administrative and staff 
support for the Task Force shall be principally 
provided by the Office of the Governor. Addition- 
al staff support may be provided by other state 
agencies as required. 

This order is effective immediately, and shall 
terminate upon completion of the Task Force's 
reported findings and recommendations. 

Done in the Capital City of Raleigh, North 
Carolina, this 26th day of August, 1993. 



The chair shall be designated by the Governor, 
and the Task Force shall meet at the call of the 
Chair. 

Section 4. Duties. 

The Task Force shall have the following duties: 
(a) Analyze existing ratios of local public 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1007 



PROPOSED RULES 



TITLE 1 - DEPARTMENfT OF 
ADMINISTRATION 

ISotice is hereby given in accordance with G.S. 
150B-21.2 that the State Employees Combined 
Campaign Advisory Committee intends to amend 
rules cited as 1 NCAC 35 .0101 - .0103, .0201 - 
.0204, .0301 - .0307 and repeal rule cited as 1 
NCAC 35 . 0303. Existing Rules 1 NCAC 35 . 0301 
- .0302, .0401 - .0407 are proposed to be recodi- 
fied as .0203 - .0204, .0301 - .0307. This notice 
reflects those recodification changes. 

A he proposed effective date of this action is 
December 1. 1993. 

Ike public hearing will be conducted at 10:00 
a.m. on October 4, 1993 at the State Library 
Building, Room 211, 109 East Jones Street, Ra- 
leigh, NC 

ixeason for Proposed Action: To clarify and 
consolidate rules applying to charitable organiza- 
tions applying for inclusion in the State Employees 
Combined Campaign. 

i^omment Procedures: Written comments should 
be submitted to: Secretary Betty Ray McCain, 
Department of Cultural Resources, 109 East Jones 
Street, Raleigh, NC 27603. 

CHAPTER 35 - STATE EMPLOYEES 
COMBINED CAMPAIGN 

SECTION .0100 - PURPOSE AND 
ORGANIZATION 

.0101 DEFINITIONS 

The puqjoso of the State Employee s Combinod 
Campaign ia to allow state employees the opportu 
nity to contribute to charitable non partisan organ! 
zations in an orderly and uniform process. — The 
contribution s are in turn granted to tho s e charities 
s elected by the S.E.C.C. Advisory Committee. 

The s e Regulations apply only to those campaign s 
in which employees are asked to malce charitable 
donations using payroll deduct i on a s method of 
payment. 

(a) "Charitable organization." A non-partisan 
organization that is tax-exempt for both the IRS 
and N.C. tax purposes. The organization must 



receive contributions that are tax deductible by the 
donor. 

(b) "Audit" or "audited financial statement." An 
examination of financial statements of an organiza- 
tion b^ a CPA. conducted in accordance with 
generally accepted auditing standards, to determine 
whether, in the CPAs opinion, the statements 
conform with generally accepted accounting 
principles or, if applicable, with another compre- 
hensive basis of accounting. 

(c) "State Employees Combined Campaign" or 
"SECC. " The official name of the state employees 
charitable fund-raising drive. 

(d) "Federation" or "Federated Group" means a 
group of voluntary charitable human health and 
welfare agencies organized for purposes of su pply- 
ing common fund-raising, administrative, and 
management services to its constituent members. 

Statutory Authority G.S. 143-3.3; 143B-10. 

.0102 PURPOSE 

Th e official nam e of the state employoco charita 
feie — fundmising — driv e — te — tbe — Stat e — Employ e es 
Combin e d Campaign (SECC). 

The purpose of the State Employees Combined 
Campaign is to allow state employees the opportu- 
nity to contribute to charitable non-partisan organi- 
zations in an orderly and uniform process. The 
contributions are in turn granted to those charities 
selected by the SECC Advisory Committee. The 
SECC is authorized to conduct a payroll deduction 
fund-raising effort among state employees. 

Statutory Authority G.S 143-3.3: 143B-10. 

.0103 ORGANIZATION OF THE 
CAMPAIGN 

The Campaign Organization is as follows: 
(I) Chair. Each year the governor Governor 
may appoint a Stat e Statewide Combined 
Campaign Dir e ctor Chair from one of the 
Executive Cabinet^^ Council of State, 
System of Community Colleges, or Uni- 
versity Administration agencies. The 
Campaign Dir e ctor Chair or the Cam- 
paign Dir e ctor's Chair's designee will 
serve as chair director of the campaign. 
The responsibilities of the chair Chair 
include setting the dates and approving 
the published materials for the Combined 
Campaign, contracting for the Statewide 
Campaign Manager, and appointing and 
serving as chair of the S.E.C.C. advisory 
committ ee SECC Advisory Committee . 



1008 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



For the purposes of selecting a Statewide 
Campaign Manager, the Statewide Com- 
bined Campaign Chair will consider the 
following criteria: 

(a) The organization must have demonstrat- 
ed ability to manage large-scale fund- 
raising campaigns. 

(b) The organization must have the ability 
and willingness to work with a state- 
wide system of local organizations 
capable of effectively managing local 
combined campaigns and relating to the 
Statewide Campaign Manager. 

(c) The organization must have an accept- 
able record of financial accountability. 

(d) The organization must be a tax-exempt 
organization under the Internal Revenue 
Code. 

(e) The organization must be willing and 
able to provide a bond in an amount 
satisfactory to the SECC Advisory 
Committee to protect the participant 
organizations and donors. 

(2) SECC Advisory Committee. This ongo- 
ing committee serves as a central applica- 
tion point for all charitable organizations 
applying to participate in the S.E.C.C. 
SECC . The committee recommends 
overall policy for the campaign to the 
Governor, the Statewide Campaign ©i- 
r e otor Chair , and necessary state agencies 
and recommends the criteria for partici- 
pation by charitable organizations. The 
committee reviews the recommendations 
made by the Statewide Campaign Manag- 
er and accepts or rejects its recommenda- 
tions. The committee may, m its discre- 
tion, require the Statewide Campaign 
Manager to provide a bond, as provided 
in Item (l)(e) of this Rule. The commit- 
tee is composed of 10 state employee 
members appointed by the Statewide 
Campaign Dir e ctor Chair. Members of 
the committ e e will initially oervo stag 
gorod torms of on e , two, and thr e e calen 
dar y e ars det e rmin e d by the Campaign 
Dir e ctor. — As each member's t e rm e x 
pires, — tfee — replac e ment — members — wttt 
s e rv e a thr ee year calendar appointment. 
Members serve three-year staggered 
terms at the pleasure of the Statewide 
Campaign Chair. If a vacancy occurs, 
the Statewide Campaign Chair shall 
appoint a replacement to fill the unex- 
pired term. Any member may be reap- 



pointed at the end of his or her term. 
(3) Statewide Campaign Manager. The 
Statewide Campaign Manager is selected 
by the Statewide Campaign Chair. The 
duties of the Statewide Campaign Manag- 
er include, but are not limited to. the 
following: 
(a) serving as the financial administrator of 

the SECC; 
(h) determining if the applicant agencies 
meet the requirements of Rule .0202 of 
this Chapter; 

(c) submitting to the Statewide Campaign 
Chair the name of an organization to 
serve as Local Campaign Manager; 

(d) providing the necessary supervision of 
data processing services in order to 
process all payroll deduction pledge 
forms of state employees; 

(e) receiving reports from the Local Cam- 
paign Manager; 

(f) transmitting to each Local Campaign 
Manager its share of the state employ- 
ees payroll deduction funds; 

(g) printing and distributing the pledge 
form, the campaign report form and 
collection envelopes to the Local Cam- 
paign Manager; 

(h) maintaining an accounting of all funds 
raised and submitting an interim unau- 
dited end-of-campaign report of the 
following: 
(i) amounts contributed and pledged; 
(ii) number of contributions; and 
(iii) amounts distributed to each participat- 
ing agency; 
(i) Once applications for acceptance into 

the campaign have been recommended 
to the SECC Advisory Committee by 
the Statewide Campaign Manager, a list 
of all accepted organizations will be 
prepared by the Statewide Campaign 
Manager and distributed to all appli- 
cants. 

S e rves as th e financial administrator for 
th e Combm e d Campaign and as such is 
r e sponsibl e for r e ceiving r e ports from 
the — leeal — Combin e d Campaigns, — fer 
transmitting to each local campaign its 
shar e of th e stat e employ e es payroll 
d e duction fund s , and for preparing an 
e nd of campaign report which summa 
rizes all fiscal campaign activity includ 
ing local audits. — TTie Statewide Cam 
paign Manager is also responsibl e for 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1009 



PROPOSED RULES 



tbe — printing — and — distribution — of th e 
pl e dg e fonii. campaign r e port form, 
and ooll e otion e nvelop e s. 

(4) Local Campaign Chair. Tlie Governor, 
if asked by the local charitable organiza- 
tions accepted into the Combined Cam- 
paign, may appoint an area representative 
from either state government or the 
University of North Carolina system to 
serve as the looal chair Local Chair . 
This person will be responsible for form- 
ing a looal — advisory committ ee Local 
Advisory Committee for recruitment of 
volunteer state employeesT^ The Local 
Chair and the Local Advisory Committee 
are jointly responsible for the approval of 
local campaign literature, the establish- 
ment of local goals as needed, and the 
distribution of any undesignated funds 
made available for distribution. 

(5) Local Campaign Manager. Ono e applioa 
tions for acc e ptance into the campaign 
have boon r e commend e d to th e Commit 
too by the Stat e wid e Campaign Manag e r, 
a list of all acc e pt e d organization s will b e 
pr e par e d — by — th e Stat e wid e — Campaign 
Manager and distribut e d to all applicants. 
Th e Stat e Campaign Manag e r will submit 
to th e Stat e Combin e d Campaign Dir e ctor 
the nam e of an ag e ncy to se rv e a s th e 
local campaign manag e r. The Campaign 
Dir e ctor Chair will approve or reject the 
State Campaign Manager's recommenda- 
tion and has the right to name the Local 
Campaign Manager. The Local Cam- 
paign Manager must identify itself on all 
printed materials as the local manager of 
the SECC rather than of any other orga- 
nization. 

(a) For the purpose of selecting a Local 
Campaign Manager, the Statewide 
Campaign Chair and Statewide Cam- 
paign Manager will consider the follow- 
ing criteria: 
(i) be a local organization willing to 

conduct a local SECC; 
(ii) comply with the terms of the 

State/Local Managers contract; 
(iii) have a broad base of community and 
state employee support and volunteer 
involvement; 
(iv) have a demonstrated ability and suc- 
cessful history of managing fund- 
raising campaigns that include: 
(A) development of campaign strate- 



ID) 

im 

IE) 



development of campaign materi- 
als; 

development of volunteer cam- 
paign structures; 
training of volunteer solicitors; 
have a financial structure and 
resources that can efficiently 
account for, and disburse 



manage, 
funds; 

be a participant organization of 
the campaign; 

must be able to develop financial 
relationships with a network of 
statewide organizations so as to 
ensure the orderly transmittal, 
disbursement, accounting of, and 
reporting of donations and pledg- 
es. 
fb) The local — manag e r Local Campaign 
Manager is responsible for assisting the 
Local Campaign Chair and Local Cam- 
paign Advisory Committee in the print- 
ing and distribution of campaign litera- 
ture, the collection of pledge reports 
and envelopes from the state agency 
volunteers, the development of cam- 
paign reports, and the forwarding of 
one copy of each payroll deduction 
pledge to the Statewide Campaign 
Manager. In addition, an end of cam- 
paign report shall be sent to the State- 
wide Campaign Manager for inclusion 
in the required fiscal reports. 
(c) The Local Campaign Manager is re- 
sponsible for the following: 
(i) establishing an account with a bank in 
order to receive deposits of collected 
funds; and 
(ii) distributing the funds from the contri- 
butions in accordance with designa- 
tions made by state employees. Un- 
designated funds will be distributed 
according to A PA regulations govern- 
ing the SECC. 
Note: A contract between the state and the State- 
wide Campaign Manager, and the state Statewide 
and local manag e r Local Campaign Managers , will 
be executed in order to develop an acceptable audit 
trail. The contracts will allow a reasonable charge 
for campaign expenses to be claimed by the State- 
wide Campaign Manager and the local manag e r 
Local Manager . All terms and conditions of these 
contracts are subject to review and approval by the 
Statewide Campaign Dir e ctor Chair . 



1010 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



Statutory Authority G.S. 143-3.3; 143B-10. 

SECTION .0200 - APPLICATION PROCESS 
AND SCHEDULE 

.0201 APPLICATIONS 

To be eligible to participate in the State Employ- 
ees Combined Campaign, an organization must 
apply annually for consideration, either as an 
independent organization or as a group of organi 
zations federation . 

Statutory Authority G.S. 143-3.3; 143B-10. 

.0202 CONTENT OF APPLICATIONS 

(a) All organizations seeking inclusion in the 
campaign must submit an application to the state 
campaign. The application must include a com- 
pleted State Employees Combined Campaign 
Certificate of Compliance, provided by the State- 
wide Campaign Manager. Included in or attached 
to the Certificate of Compliance must be: 

(1) A letter from the board of directors 
requesting inclusion in the campaign. 

(2) A complete description of services 
provided, the service area of the orga- 
nization, and fund-raising/administrative 
costs. 

(3) The most recent audited financial state- 
ment prepared by a CPA within the 
past two years. The year end of such 
audited financial statement must be no 
earlier than two years prior to the 
current year's campaign date. The 
SECC Advisory Committee may grant 
an exception to this requirement if an 
organization has filed its Articles of 
Incorporation with the Secretary of 
State's Oflice since March i of the 
preceding year of the current campaign. 

(4) A board statement of assurance of non- 
discrimination of employment, board 
membership and client services. 

(5) A description of the origin, purpose and 
structure of the organization. 

(6) A list of the current members of the 
board, including their addresses. 

(7) A letter from the board of directors 
certifying compliance with the eligibili- 
ty standards listed in Paragraph (b) of 
this Rule. 

(8) When a federated fund-raising organiza- 
tion submits an application they may 
submit the credentials of the federation 
only, not each member agency. By the 



submission of such, the federations 
certify that all of their member agencies 
comply with all the SECC regulations, 
unless there are exceptions. If there are 
exceptions to the requirements, the 
federations must disclose such and 
explain to the satisfaction of the State- 
wide Combined Campaign Advisory 
Committee the reasons for the excep- 
tion, 
(b) Organizations must meet the following 
criteria to be accepted as participants in the Com- 
bined Campaign: 

(1) The organization must be licensed to 
solicit funds in North Carolina if a 
license is required by law . 

(2) Have Must provide written proof of tax 
exempt status for both th e IRS federal 
and N.C. tax purposes. Organizations 
must certify that contributions from 
state employees are tax deductible by 
the donor under N.C. and federal law. 

(3) Must prepare and make available to the 
general public an annual audited finan- 
cial statement. , r e port or IRS Form 
99Gt The SECC Advisory Committee 
may grant an exception to this require- 
ment if an organization has filed its 
Articles of Incorporation with the Sec- 
retary of State's Office since March \ 
of the preceding year of the current 
campaign. An e xc e ption to thi s ro 
quirement is provid e d for any organiza 
tion whioh — hoo fil e d its — Articl e s of 
Inoorpomtion — with — the — S e cretary — ef 
Stat e 's Offico as of March 1, of the 
pr e c e ding y e ar of the curr e nt campaign. 

(4) If fund-raising and administrative ex- 
penses are in excess of 25 percent of 
total revenue, the organization must 
demonstrate to the satisfaction of the 
SECC that those expenses for this 
purpose are reasonable under all the 
circumstances of the case. 

(5) Must certify that all publicity and pro- 
motional activities are truthful and non- 
deceptive and that all material provided 
to the SECC is truthful and non-decep- 
tive . 

(6) Must agree to maintain the confidential- 
ity of the contributor list. 

(7) Must permit no payments of commis- 
sions, kickbacks, finders fees, percent- 
ages, bonuses, or overrides for fund; 
raising, and permit no paid solicitations 



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PROPOSED RULES 



of the public. 

(8) Must have a policy of non-discrimina- 
tion on the basis of race, color, reli- 
gion, sex, age, national origin or physi- 
cal or mental handicap disability for 
clients of the agency, employees of the 
agency and members of the governing 
board. 

(9) Must provide benefits or services within 
the local community, meaning that 
employees in the solicitation area or 
their femilies should be able to receive 
benefits or services from the agency 
within a reasonable distance , or r e c e iv e 
benefits — from — voluntary — agonoios . 
Examples of services are include : 

(a) (A) research and education in the 
health and welfare or education fields; 

(fe) £B} family and child care services; 

{©) iC) protective services for children 
and adults; 

(4) (D) services for children and adults in 
foster care; 

^ £E} services related to the manage- 
ment and maintenance of the home; 

{^ £F} day care services for adults and 
children; 

(g) (G) transportation services, informa- 
tion referral and counseling services; 

(b) (H) the preparation and delivery of 
meals; 

(i) £1} adoption services; 

{j) (J) emergency shelter care and relief 

services; 
{k) (K) safety services; 
(i) £L) neighborhood and community 

organization services; 
(ffl) (M) recreation services; 
(fi) (N) social adjustment and rehabilita- 
tion services; 
{e) £0} health support services; or 
{p) ££} a combination of services de- 
signed to meet the needs of special 
groups such as the elderly or handi 
capped disabled . 
However, an international organization which 
provides health and welfere services overseas, 
whose activities do not require a local presence 
and which meet other eligibility criteria, may be 
accepted for participation in the campaign. 

Statutory Authority G.S. 143-3.3; MSB- 10. 

tOMI .0203 SCHEDULE 

Complete applications must be submitted to the 



Stat e Statewide Combined Campaign Advisory 
Committee by February 15 annually to be included 
in the fall campaign. Incomplete applications may 
not be considered by the committee. The Chair 
will forward all application materials to the State- 
wide Campaign Manager within three working 
days after the closing deadline. The Statewide 
Campaign Manager will report to the Committee 
its recommendation on each application within 
three weeks of the closing deadline. The Commit- 
tee shall affirm or reject each recommendation by 
the Statewide Campaign Manager and will inform 
the Statewide Campaign Manager of its decisions. 

Statutory Authority G.S. 143-3.3; 143B-10. 

.MQ2 .0204 RESPONSE 

All applicants will be notified by the Statewide 
Campaign Manager of the Committee's decision 
within 50 45 days of the closing deadline. An 
applicant who is dissatisfied with the determination 
of its application may file an appeal to the State 
Advisory Committee within 10 days of the notifi- 
cation dispatch postmark date. An applicant who 
is dissatisfied with either the committ e e's 
Committee's decision or the appeal determination 
of the committ ee Committee may commence a 
contested case by filing a petition under 150B-23 
within 60 days of notification dispatch postmark 
date of the Committee's decision. 

Statutory' Authority' G.S 143-3.3; 1438-10. 



.0303 



AH- 



FORM AND CONTENT OF 
APPLICATION 



organizations s e eking funding must submit an 
application to th e stat e campaign. Th e application 
mu s t — includ e — the — State — Employees — Combin e d 
Campaign C e rtificate of Compliance. — Includ e d in 
or attach e d to th e C e rtificat e of Complianc e must 
be- 



w- 



-A 



ett e r — from — the — board — of dir e ctors 
indicating interest. 



(3) A compl e te description of service s pro 

vid e d. and th e s e rvic e area of th e organi 
zntion. 

{54 The most recent audited financial s tate 

ment pr e pared by a CPA. — An e xc e ption 
to this r e quir e m e nt is provid e d for any 
organization which has filed its Articl e s 
of Inoorpomtion with th e S e cr e tary of 
Stat e 's — Offic e — as of March — ]-, — of th e 
preceding y e ar of th e curr e nt campaign. 

f4) A board stat e m e nt of assuranc e of non 

discrimination. 



1012 



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PROPOSED RULES 



^^ 



m- 



f^ 



A d e soription of tho origin, purpoo e and 
Btruoturo of th e organization. 
A list of th e current m e mb e rs of th e 
board, including addr e ss e s. 
A l e tt e r oortilying compliance with th e 
eligibility standards list e d in Rule .0202 
of this — Chapt e r — including — ta* — exempt 
status, licensing, and showing the per 
o e ntag e of funds e xp e nd e d in th e catego 
ri e s of Program and S e rvic e , Manag e 
m e nt and Gen e ral (Administrativ e ) and 
Fundmising. 



Statutory Authority G.S. 143-3.3; 143B-10. 

SECTION .MOO .0300 - GENERAL 
PROVISIONS 

.«401 .0301 OTHER SOLICITATION 
PROfflBITED 

Not more than one on-the-job solicitation for 
funds will be made in any year at any location on 
behalf of participating SECC agencies. The 
prohibition does not include Red Cross sponsored 
Bloodmobiles or employee association solicitations. 
Th e Stat e Employ ee Combin e d Campaign is the 
only authorized payroll d e duction fund raising 
e ffort among state omployoos. 



Payment may be made by payroll deduction, 
cash, pl e dge, or personal check. If an employee 
chooses to use the payroll deduction method of 
contributing, he/she must agree to having have the 
deduction continue for one year with equal 
amounts being talcen deducted from each check 
(monthly or biweekly depending on the payroll). 
All deductions will start with the January payroll 
and continue through December. If the employee 
discontinues employment, or actively chooses to 
discontinue payment, the state will not be responsi- 
ble for the collection of the unpaid pledge. No 
deduction will be made for any period in which the 
employee's net pay, after all legal and previously 
authorized deductions, is insufficient to cover the 
allotment. No adjustments will be made in subse- 
quent periods to make up for deductions missed. 

Statutory Authority G.S 143-3.3; 143B-10. 

t0404 .0304 CAMPAIGN LITERATURE 

Each charitable organization accepted as a part of 
the campaigUT must provide adequate information 
about its servicesT including administrative/fund- 
raising costs, to the local campaign manager Local 
Campaign Manager for use in the local campaign. 

Statutory Authority G.S 143-3.3; 143B-10. 



Statutory Authority G.S 143-3.3; 143B-10. 

t0403 .0302 COERCIVE ACTIVITIES 
PROfflBITED 

(a) In order to insure that donations are made on 
a voluntary basis, actions that do not allow free 
choice or that create an impression of required 
giving are prohibited. Peer solicitation is encour- 
aged. Employee Employ ee s gifts are kept confi- 
dentialT^ except that employees may opt to have 
their designated contributions acknowledged by the 
recipient organizations. 

(b) The following activities are not permitted: 

(1) The Providing providing and using of 
contributor lists for purposes other than 
the routine collection^ and forwarding^ 
and acknowledgement of contributions. 

(2) TTie establishment of personal dollar 
goals or quotas. 

(3) The developing and using of lists of 
non-contributors. 

Statutory Authority G.S. 143-3.3; 143B-10. 

t0403 .0303 PAYMENT METHOD AND 
TERMS OF CONTRIBUTION 



t040S .0305 DESIGNATION CAMPAIGN 

Each employee will be given the opportunity to 
designate which agency or group of agencies 
should benefit from his or her contribution to the 
State Employees Combined Campaign. Each 
employee will be given a listing list of the ap- 
proved agencies in the campaign in order to help 
them make the decision. 

Statutory Authority G.S. 143-3.3; 143B-10. 

.0406 .0306 DISTRIBUTION OF 
UNDESIGNATED FUNDS 

All contributions made through the S.E.C.C. 
SECC should be designated to a particular recipi- 
ent. Any monies not designated to a particular 
recipient shall be deemed as undesignated funds. 
Undesignated funds shall be allocated by the 
S.E.C.C. SECC to the oounty/ local S.E.C.C. 
SECC committees. The oounty/ local S.E.C.C. 
SECC shall distribute these funds within their 
communities. 

Statutory Authority G.S. 143-3.3; 143B-10. 

.0407 .0307 EFFECTIVE DATE OF 



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September 15, 1993 1013 



PROPOSED RULES 



AMENDED RULES 

These amended rules shall b e com e offootivo ao 
gpooifi e d by statute and ohall apply to all applioa 
tions — then — p e nding — or thereaft e r approv e d be 
effective for the 1994 SECC and thereafter . 

Statutory Authority G.S. 143-3.3; 143B-10. 

TITLE 10 - DEPARTMENT OF 
HUMAN RESOURCES 

l\otice is hereby given in accordance with G.S. 
150B-21.2 that the Division of Facility Services 
intends to adopt rules cited as 10 NCAC 3R .0214, 
.1213- .1219, .1413- .1419,. 1619, .1720. .1912 

- .1918. .2120, .2314 - .2320, .2713 - .2719. 
.3101 -.3108, .3201 - .3207, .3301 -.3306, .3401 

- .3407, .3501 - .3507, .3601 - .3607. .3701 - 
.3707. .3801 - .3807, .3901 - .3908, .4001 - 
.4012, .4101 - .4107; amend rules cited as 10 
NCAC 3R .0304. .0309. .0321, .1613 - .1618, 
.1713 - .1715. .1717 - .1719, .2113 - .2119; and 
repeal rules cited as 10 NCAC 3R .1202 - . 1209, 
. 1402. . 1404 - . 1409, .1716, . 1902, . 1904 - . 1908, 
.2702- .2707, .2710- .2711. 

1 he proposed effective date of this action is 
January- 4, 1994. 

1 he public hearing will be conducted at 10:00 
a.m. on October 29, 1993 at the Council Building, 
Room 201. 701 Barbour Drive, Raleigh, North 
Carolina 27603. 

Keason for Proposed Action: 

10 NCAC 3R .1202 - .1209, .1213 - .1219, .1617 

■ .1619, .1716, .1720, .2120, 4101 - .4107 - 

Repeal existing "intensive care service", "open 
heart surgical services" rules and adopt rules 
which would incorporate current medical practices 
and technologies. Amend existing and establish 
criteria and standards for review of CON applica- 
tions for Pediatric Intensive Care Services, Cardi- 
ac Catheterization Services and Ambulatory Sur- 
gery Services. 

10 NCAC 3R .1614, .1615 - .1616, .2115, .2117, 
.2118 - To adopt as permanent rules amendments 
to the temporary rules adopted effective September 
1 , 1993, which amend existing criteria and stan- 
dards for Cardiac Catheterization Services and 
Ambulatory Surgical Services. 
10 NCAC 3R .0214, .2314 - .2320, .3101 - .3108, 



.3201 - .3207, .3301 - .3306, .3401 - .3407, .3501 

- .3507, .3601 - .3607, .3701 - .3707, .3801 - 
.3807, .3901 - .3908, .4001 - .4012 - To adopt as 
permanent rules the temporary rules adopted 
effective September 1 , 1993, which amend existing 
and establishes criteria and standards pursuant to 
Senate Bill 10 which was ratified on March 18, 
1993. 

10 NCAC 3R .1402, .1404 - .1409, .1413 - .1419, 
.1902, .1904 - .1908, .1912 - .1918, .2702 - 
.2707, .2710 - .2711, .2713 - .2719 - To repeal 
existing rules and adopt as permanent rules the 
temporary rules adopted effective September 1, 
1993 which establishes criteria and standards 
pursuant to Senate Bill 10 which was ratified on 
March 18, 1993. 
10 NCAC 3R .0304, .0309, .0321, .1613, .1713 

- .1715, .1717 - .1719, .2113 ■ .2114, .2116, 
.2119 - To adopt as permanent rules the temporary 
rules adopted September 1, 1993 which amends 
existing and establishes criteria and standards 
pursuant to Senate Bill 10 which was ratified on 
March 18, 1993. 

i^omment Procedures: All written comments must 
be submitted to Jackie Sheppard, APA Coordina- 
tor, Division of Facility Services, P. O. Box 
29530. Raleigh, NC 27626-0530. telephone (919) 
733-2342, up to and including October 29, 1993. 
Written comments submitted after the deadline will 
not be considered. 

Auditor's Note: Temporary rules have been filed 
effective September 1, 1993 with the exception of 
Rules 10 NCAC 3R .1202 - .1209, .1213 - .1219, 
.1617 - .1619, .1716, .1720, .2120 and .4101 - 
.4107. The text of the temporary rules may differ 
from the proposed permanent rules published in 
this notice. The temporary rules can be obtained 
by contacting the Office of Administrative Hear- 
ings, Rules Division at (919) 733-2678. 

CHAPTER 3 - FACILITY SERVICES 

SUBCHAPTER 3R - CERTIFICATE OF 
NEED REGULATIONS 

SECTION .0200 - EXEMPTIONS 

.0214 REPLACEMENT EQUIPMENT 

(a) The purpose of this Rule ]s to define the 
terms used in the definition of "replacement 
equipment" set forth in G.S. 131E-176(22a). 



1014 



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PROPOSED RULES 



(h) "Activities essential to acquiring and making 
operational the replacement equipment" means 
those activities which are indispensable and requi- 
site: absent which the replacement equipment 
could not be acquired or made operational. 

(c) "Comparable medical equipment" means 
equipment which is functionally similar and which 
is used for the same diagnostic or treatment pur- 
poses. 

(d) Replacement equipment is comparable to the 
equipment being replaced if: 

(1) il has the same basic technology as the 
equipment currently in use, although it 
may possess expanded capabilities due 
to technological improvements; and 

(2) it is functionally similar and is used for 
the same diagnostic or treatment pur- 
poses as the equipment currently in use 
and is not used to provide a new health 
service; and 

(3) the acquisition of the equipment does 
not result in more than a 10% increase 
in patient charges or gsr procedure 
operating expenses within the first 
twelve months after the replacement 
equipment is acquired; and 

(4) it will be located on the same site or 
campus as the equipment currently in 
use. 

(e) Replacement equipment is not comparable to 
the equipment being replaced ifi 

(1) the replacement equipment is new or 
reconditioned, the existing equipment 
was purchased second-hand, and the 
replacement equipment is purchased 
less than three years after the acquisi- 
tion of the existing equipment; or 

(2) the replacement equipment is new, the 
existing equipment was reconditioned 
when purchased, and the replacement 
equipment is purchased less than three 
years after the acquisition of the exist- 
ing equipment; or 

(3) the replacement equipment is perma- 
nently fixed equipment and the existing 
equipment is one piece of mobile equip- 
ment which is shared between two or 
more facilities. 



(a) After receipt of a letter of intent, the agency 
shall determine whether the proposed project 
requires a certificate of need. In molcing this 
d e oiaion th e ag e ncy shall consid e r th e obligation of 
a capital expenditur e on b e half of or for a h e alth 
s e rvic e faoility to b e : 

(4^ an exp e nditure to bo obligated or in 

ourr e d by th e facility'; 

{3) an e xp e nditur e to be obligat e d or in 

ourr e d by any person, board or organi 
zation having own e rship or control of 
th e faoility, or ov e r which tho facility' 
has ownership or control and which 
r e lat e s to th e provision of a hoalth 
s e rvic e ; 

0) an e xpenditur e to bo obligat e d or in 

ourr e d by any person, board or organi 
zation with which th e faoility has a 
contractual r e lationship to provide or 
purchase s e rvic e s, or shar e spaco, profit 
or e xp e ns e s — m — oonnootion — w4tfe — the 
provision of a h e alth service; or 

(4) an e xpenditure to be obligat e d or in 

ourr e d by any p e rson, board or organi 
zation dev e loping a health service on 
property owned or leas e d to or by the 
faoility. 

(b) If it is determined that the project requires a 
certificate of need, the agency will determine the 
appropriate review category or categories for the 
proposed project, the type or types of application 
forms to be submitted, the number of separate 
applications to be submitted, the applicable review 
period for each application, and the deadline date 
for submitting each application. 

(c) Copies of the application forms may be 
obtained from the agency. 

(d) Proposals requiring review will be reviewed 
according to the categories and schedule set forth 
in the duly adopted State Medical Facilities Plan in 
effect at the time scheduled review period com- 
mences. 

(e) Applications are competitive if they, in 
whole or in part, are for the same or similar 
services and the agency determines that the ap- 
proval of one or more of the applications may 
result in the denial of another application reviewed 
in the same review period. 



Statutory Authority G.S. 13] £-177(1). 



Statutory Authority G.S 131E-177; 131E-182. 



SECTION .0300 - APPLICATION AND 
REVIEW PROCESS 

.0304 DETERMINATION OF REVIEW 



.0309 REVIEW PERIOD 

(a) The review of an application for a certificate 
of need shall be completed within 90 days from the 
beginning date of the review period for the appli- 



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1015 



PROPOSED RULES 



cation, except as provided in Paragraph (b) of this 
Rule. 

(b) Except in the case of an expedited review, 
Tb« the period for review may be extended for up 
to 60 days by the agency if it determines that, for 
one or more of the following reasons, it cannot 
complete the review within 90 days: 

(1) the extension is necessary to consider 
conflicting, contradictory, or otherwise 
relevant matters; 

(2) the total number of applications 
assigned to the project analyst for 
review, including those in other review 
periods, preclude the project analyst 
from completing the review within 90 
days; 

(3) the complexity of the application or 
applications to be reviewed make it 
necessary to extend the review period; 

(4) the review of an applicant's response to 
the agency's request for additional 
information has not been completed; 

(5) the timing of the public hearing which 
was held for the application or 
applications under review does not 
allow sufficient time to consider the 
information presented; 

(6) extension of previous reviews 
necessitated that the project analyst 
delay the commencement of the review; 
or 

(7) the unavailability of the project analyst 
due to illness, annual leave, litigation 
associated with other reviews, or other 
duties and responsibilities. 

(c) In the case of an expedited review, the 
review period may be extended only if the Agency 
has requested additional substantive information 
from the applicant in accordance with G.S. 131E- 
185(c). 

(d) (e) Applicants will be provided written 
notice of the extension of the review period after 
the agency determines that an extension is 
necessary. Failure to receive such notice prior to 
the last day of the scheduled review period, 
however, does not entitle an applicant to a 
certificate of need nor authorize an applicant to 
proceed with a project without one. 

Statutory Authority G.S. 131E-177; 131E-185. 

.0321 EXPEDITED REVIEW 

(a) An applicant which desires an expedited 
review shall submit a petition for an expedited 
review with the Certificate of Need Section when 



the application is submitted. 

(b) The Certificate of Need Section shall review 
the petition within 15 days from the beginning of 
the review and shall notify the applicant if the 
Agency has determined that a public hearing is in 
the public interest. 

(c) If the Certificate of Need Section decides 
that it is not in the public interest to hold a public 
hearing, a final determination on the request for an 
expedited review shall not be issued until after the 
thirty day written comment period has expired. 

(dj If a request for a public hearing is received 
by the Agency during the 30 day written comment 
period, which is defined in G.S. 131E-185, the 
re quest for an expedited review shall be denied. 

(e) After the thirty day written comment period, 
the Certificate of Need Section shall notify the 
applicant that its petition for an expedited review 
is approved or denied. 

Statutory Authority G.S. 131E-177(1). 

SECTION .1200 - CRITERIA AND 

STANDARDS FOR INTENSIVE CARE 

SERVICES 

.1202 DEFINITIONS 

TTie definitions in this Rule will apply to all rules 
in this S e ction: 



W- 



4f 



thos e 



Int e nsive — eere — servic e s — m e ans 
s e p . 'ioes provid e d by an acute care caro 

hospital te pati e nts who r e quire 

continuous. — compr e h e nsiv e — obs e rvation 
and a high level of nursing cor e . 

(3) "Intensiv e car e unit" means a s e parat e 

s e lf suffici e nt — e ntity — within — which — aH- 

n e cessary supplie s and e quipment 

e ssential — te — provid e — int e nsiv e — eare 

s e rvices afe availabl e — te pati e nts 

r e quiring th e m. — This does not includ e 

post op e rativ e r e covery rooms, 

po s t d e liv e ry rooms. ef — em e rg e ncy 

ob se rvation unita. 



Statutory Authority G.S 1 31 E- 177(1). 

.1204 CAPACIT\ IN THE FACILITY AND 
IN THE HEALTH SERVICE AREA 

(e^ — Proposals fil e d by or on behalf of hospital 
faciliti e s — fef — int e nsive — esfe — s e rvices — must — be 
consist e nt with th e applicabl e North Carolina Stat e 
M e dical Faciliti e s Plan, with th e applicabl e North 
Carolina Stat e Health Plan (the one in eff e ct at 
tifiw — of final — ag e ncy — d e cision) — aed — with — the 
applicable h e alth syst e ms plan. 



1016 



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PROPOSED RULES 



{b3 Propooalo — involving — new — ef — expand e d 

intonoivo oar e bods must op e oif^' th e numbero of 
int e nsive oaro boda to bo op e rat e d following the 
oompl e tion of the proposed proj e ct. 

(e) — A proposal involving additional int e nsiv e 
caro b e ds shall not b e approv e d unless tho overall 
as'omgo annual oooupanoy, over th e — 12 months 
immediat e ly — pr e c e ding — the — submittal — ef — the 
proposal, of th e total number of funotional e xisting 
intensiv e oaro bods in th e facility in which th e 
propos e d b e ds ar e to bo op e rat e d i s at least 70 
percent in unite with 20 or more intensive oare 
bods, 65 p e rc e nt in units with 10 19 intensiv e oar e 
bods, and 60 perc e nt in units with 1 9 intensiv e 
oare b e ds. 

Statutory Authority G.S. 1 31 E- 177(1). 

.1205 SCOPE OF SERVICES OFFERED 

A proposal to provid e n e w or expand e d int e nsiv e 
car e s e rvic e s must document th e extent to which 
tho following will bo available. — If any it e m will 
not b e available, then substantiv e information must 
bo giv e n obviating tho need for that it e m befor e 
approval for a nov' i ' or e xpanded s e rvic e can b e 
given: 

(4^ e — distinct, — identifiable — area — fef — the 

provision of int e nsiv e care s ervice s ; 

(S) tw e nty four hour on call availability of 

laboratory and radiology s e rvic e s; 

{i) 0; /air/suction capability; 

(4) el e ctronic cardiovascular monitoring 

capability; 

(§) capabiliti e s for e ndotrach e al intubation, 

m e chanical — v e ntilatory — assistanc e , — asd 
oardiao pac e malc e r ins e rtion; 

{6) oardiao arr es t manag e m e nt plan; 

f7) twenty four hour blood banlt. 

Statutory Authority G.S. 131E-177(1). 

.1206 PROJECTED UTILIZATION/ 
OCCUPANCY 

(a) — A proposal to provide new or expand e d 
intensive care servic e s must proj e ct an occupancy 
l e v e l for th e total int e nsiv e car e s e rvices for e ach 
of th e fir s t eight cal e ndar quarter s following th e 
oompl e tion of the propo se d proj e ct. An occupancy 
lev e l mu s t also bo projected for each s p e cializ e d 
type of intensiv e car e servic e to the ext e nt that 
s pecializ e d types of service ar e proposed to be 
operat e d . — All assumptions, including the opooifio 
methodologi e s by which occupancies are projected, 
must b e olearly stat e d. 

•(b) — A proposal to provide new or expand e d 



int e nsiv e care services shall not be approv e d unl e ss 
oooupanoy is proj e ct e d to b e at least 75 percent for 
th e total numb e r of int e nsiv e car e beds propos e d to 
bo operated, no later than thr ee y e ars following the 

oompl e tion — ef — the — proposed — proj e ct. AH 

assumptions, including th e sp e cific methodologi e s 
by — which — occupancies — ar e proj e cted, — must — be 
olearly stat e d. 

(o) A proposal to e stablish a n e ' . ' . ' int e nsive oaro 
or coronary oar e unit shall not b e approv e d unless 
th e utilization of tho unit is proj e ct e d to b e at least 
at a rat e of 4 b> e ds at 75 p e rc e nt occupancy no 
lat e r than throe y e ars following th e oompl e tion of 
th e propos e d proj e ct. 

Statutory Authority G.S. 131E-177(1). 

.1207 PROJECTED PATIENT ORIGIN 

(a) — A proposal to provid e n e w or expand e d 
int e nsiv e car e s e rvic e s must proj e ct patient origin 

by — percentage — by — county — of r e sid e nc e . AH 

assumptions, including th e sp e cific methodology 
by whioh patient origin is proj e ct e d, must b e 
clearly stat e d. 

(b) — A proposal to provid e n e w or expand e d 
int e nsiv e car e s e rvic e s must show that at l e ast 90 
percent of th e anticipat e d patient population is 
within — 45 — minut e s — automobil e — driving — tiffle 
(on e way) from th e facility, with th e exception that 
th e r e — h*^" — be — varianc e — from — the — 90 — percent 
standard for institutions traditionally off e ring v e ry 
s p e cialized levels of intensive oare to a large and 
g e ographically div e rs e population. 

Statutory Authority G.S. 131E-177(1). 

.1208 SITE AND EQUIPMENT 

(a) — A proposal to provide new or e xpand e d 
int e nsiv e oar e se rvic e s must provid e docum e ntation 
to shov/ that the se rvices will b e offer e d in a 
phy s ical — environment — that — conform s — te — the 
r e quirem e nts of f e deral, stat e , and local regulatory 
bodi es . 

(fe) — A proposal to provide new or expand e d 
intensive care services must document the extent to 
which — th« — following, — r e quir e d — by — th« — Joint 
Commi ss ion on Accr e ditation of Ho s pital s , will be 
availabl e . — If any item will not be availabl e , then 
substantiv e information mu s t b e giv e n obviating 
the n e ed for that it e m befor e approval for a n e w or 
expand e d se rvic e can be giv e n: 

ft) oxygon — and — compr e ss e d — air and th e 

m e an s of administration; 

(3) mechanical v e ntilatory assistanc e 

e quipm e nt — including airways, — manual 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1017 



PROPOSED RULES 



(^ 



br e athing bag and v e ntilator/reopimtor; 
oard i QO d e fibrillator with 



synohronization capability; 
(43 r e spiratory — afld — oardiao — monitoring 

e quipm e nt; 
(5^ thorano e ntooio and clos e d thoroostomy 

tmohoootomy sot; 






toumiqucto; 

f&3 vascular outdovvn o e ts; 

(9) infusion pumps; 

(+0) laryngoscopes and e ndotrach e al tub e s; 

(44^ trach e obronchial — and — gastric — suction 

equipm e nt; 

portable x my; 






pati e nt — weighing — devic e — fef — bed 
patients. 



Statutory Authority G.S. 131 £-177(1). 

.1209 STAFFEVG 

(e) A proposal — te — offer new — or e xpand e d 

intensive care servic e s mu s t provide documentation 
to show that the appropriat e t^'pes and numbers of 
s taff", particularly qualifi e d m e dical and nursing 
staff", will be available to support the services. 

fb) A — proposal — te — off e r — new — ef — e xpand e d 

intensive car e s e rvices must provid e docum e ntation 
to show that such s e rvic e s will be coordinat e d by 
a regist e r e d nurs e who — has formal training in 
int e nsive care nursing. 

Statutory Authority G.S 131 £-177(1). 

.1213 DEFINITIONS 

The definitions in this Rule shall a pply to all 
rules in this Section: 

"Intensive care services" means those 



m 



£2} 



services provided by an acute care 
hospital to patients with a wide variety of 
illnesses of a life-threatening nature, 
including patients with highly unstable 
conditions which require so phisticated 
medical and surgical intervention and a 
high level of nursing care and those 
patients which require continuous, 
comprehensive observation. 
"Intensive care unit" means a separate 
self-sufficient entity which has all 
supplies, equipment, and staff necessary 
to offer intensive care services twenty- 
four hours a day, seven days a week. 
TTie term does not include post-operative 
recovery rooms, post-delivery rooms, or 
emergency observation units. 



Statutory Authority G.S. 131 £-177(1). 

.1214 INFORMATION REQUIRED OF 
APPLICANT 

(a) Applicant that proposes new or expanded 
intensive care services shall use the Acute Care 
Facility/Medical Equipment application form. 

(b) A pplicant proposing new or expanded inten- 
sive care services shall also submit the following 
additional information: 

(1) the number of intensive care beds cur- 
rently operated by the applicant and the 
number of intensive care beds to be 
operated following completion of the 
proposed project; 

(2) documentation of the applicant's experi- 
ence in treating patients at the facility 
during the past twelve months, includ- 
ing: 

(A) the number of inpatient days of care 
provided to intensive care patients; 

(B) the number of patients initially treated 
at the facility and referred to other 
facilities for intensive care services; 
and 

(C) the number of patients initially treated 
at other facilities and referred to the 
applicant's facility for intensive care 
services. 

(3) the number of patients from the pro- 
posed service area who are projected to 
require intensive care services by the 
patients' county of residence in each of 
the first 12 quarters of operation, in- 
cluding all assumptions and methodolo- 
gies; 

(4) the projected number of patients to be 
served and inpatient days of care to be 
provided by county of residence by 
specialized type of intensive care for 
each of the first twelve calendar quar- 
ters following completion of the pro- 
posed project, including all assumptions 
and methodologies; 

(5) correspondence from the proposed 
referral sources documenting their 
intent to refer patients to the applicant's 
facility; 

(6) documentation which demonstrates the 
applicant's capability to communicate 
effectively with emergency transporta- 
tion agencies, 

(7) documentation of written policies and 
procedures regarding the provision of 
care within the intensive care unit. 



1018 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



which includes, but js riot limited to the 
following: 

(A) the admission and discharge of pa- 
tients: 

(B) infection control: and 

(C) safety procedures; 

(8) documentation that the proposed service 
shall be operated in an area organized 
as a physically and functionally distinct 
entity, separate from the rest of the 
facility, with controlled access; 

(9) documentation to show that the services 
shall be offered in a physical environ- 
ment that conforms to the requirements 
of federal, state, and local regulatory 
bodies: 

(10) a detailed floor plan of the proposed 
area drawn to scale: and 

(1 1) documentation of a means for observa- 
tion by unit stafF of alj patients ]n the 
unit from one vantage point. 

Statutory Authority G.S. 131E-177(1}. 

.1215 REQUIRED PERFORMANCE 
STANDARDS 

The applicant shall demonstrate that the proposed 
project is capable of meeting the following stan- 
dards: 

(1) the overall average annual occupancy rate 
of all intensive care beds in the facility, 
excluding neonatal and pediatric intensive 
care beds, over the 12 months immediate- 
ly preceding the submittal of the propos- 
al, shall have been at least 70 percent for 
facilities with 20 or more intensive care 
beds, 65 percent for facilities with 10-19 
intensive care beds, and 60 percent for 
facilities with 1-9 intensive care beds; 

(2) the projected occupancy rate for all inten- 
sive care beds in the applicant's facility, 
exclusive of neonatal and pediatric inten- 
sive care beds, shall be at least 70 per- 
cent for facilities with 20 or more inten- 
sive care beds, 65 percent for facilities 
with 10-19 intensive care beds, and 60 
percent for facilities with 1-9 intensive 
care beds, in the third operating year 
following the completion of the proposed 
project; and 

(3) all assumptions and data supporting the 
methodology by which the occupancy 
rates are projected shall be provided. 

Statutory Authority G.S. 131E-177(1). 



.1216 REQUIRED SUPPORT SERVICES 

(a) An applicant proposing new or additional 
intensive care services shall document the extent to 
which the following items are available: 

(1) twenty-four hour on-call laboratory 
services including microspecimen chem- 
istry techniques and blood gas determi- 
nations; 

(2) twenty-four hour on-call radiology 
services, including portable radiological 
equipment; 

(3) twenty-four hour blood bank services: 

(4) twenty-four hour on-call pharmacy 



15} 



twenty-four hour on-call coverage by 
respiratory therapy: 
oxygen and air and suction capability; 
electronic cardiovascular monitoring 
capability: 

mechanical ventilatory assistance equip- 
ment including airways, manual breath- 
ing bag and ventilator/ respirator: 
endotracheal intubation capability: 
cardiac pacemaker insertion capability; 
cardiac arrest management plan; 
patient weighing device for bed 
patients; and 
isolation capability, 
(b) If any item in Subparagraphs (a)(1) - (13) of 
this Rule will not be available, the applicant shall 
document the reason why the item is not needed 



(61 

m 

18} 



19} 

(10) 

ILQ 
(12) 

(13) 



for the provision of the proposed services. 

Statutory Authority G.S. 131E- 177(1). 

.1217 REQUIRED STAFFING AND STAFF 
TRAINING 

The a pplicant shall demonstrate the ability to 
meet the following staffing requirements, in 
accordance with recommendations and standards 
from the Society of Critical Care Medicine for 
intensive care units: 

(1) nursing care shall be supervised by a 
qualified registered nurse with specialized 
training in the care of critically ill 
patients, cardiovascular monitoring, and 
life support; 

(2) direction of the unit shall be provided by 
a physician with training, experience and 
expertise in critical care; 

£3} assurance from the medical staff" that 
twenty-four hour medical and surgical 
on-call coverage is available: and 

(4) a ppropriate inservice training or 
continuing education programs shall be 



8.12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1019 



PROPOSED RULES 



provided for the intensive care staff. 
Statutory Authority G.S. 131 £-177(1). 

.1218 ACCESSIBILITY 

(a) The applicant shall provide documentation 
describing the mechanism that will be used to 
insure that the projected number of medically 
underserved will be served in the facility. 

(b) The applicant shall provide written 
admissions policies identifying any prepayment or 
deposit requirements for the facility and 
specifically stating the admission requirements for 
patients in each of the following payor categories: 

(1) Medicare; 

(2) Medicaid; 

(3) Blue Cross and Blue Shield; 

(4) Commercial Insurance; 

(5) State Employees Health Plan; 

(6) Self-Pay (includes self-pay, indigent 
and charity care); and 

(7) Other as identified by the applicant. 

(c) The applicant shall provide a written 
description of the billing procedures, including the 
credit and collection policies that will be utilized 
by the facility. 

(d) The applicant shall document that the health 
care community in the service area, including the 
Departments of Social Services and Health, have 
been invited to comment on the proposed project, 
particularly with regard to the facility's referral 
mechanisms and admissions policies for the 
medically underserved. 

Statutory Authority G.S 131E-177(1). 

.1219 DATA REPORTING REQUIREMENTS 

The facility shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information, in 
accordance with data format and reporting 
requirements formulated by the Division of 
Facility Services: 

(1) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S. 131 £-177(1). 

SECTION .1400 - CRITERIA AND 
STANDARDS FOR NEONATAL SERVICES 

.1402 DEFINITIONS 

Th e d e finitions in this Rul e will apply to all rul e s 
in this Section: 



■(4^ "Normal n e wborn ocrvicoo" mcano those 

routin e Bervioes — provid e d by an acute 
oar e hospital to — normal fiill t e rm -asd 
normal pr e t e rm infante weighing at loost 
2000 grams at birth. Routin e oaro within 

th+fi cont e xt includes incr e ased 

observation, screening, and otabilization 
e# — infants — within — tbe — fi«t — ieuf — te 
tw e nty four hours following birth. 
"N e onatal — continuing — eaf=e — services" 



(3)- 



m- 



m e ans — those — s e rvices — provided — by — aa 
acute care hospital to low birth w e ight 
infants who are not sick but who require 
fr e qu e nt f ee ding, infants who no longer 

require neonatal interm e diate eare 

s e rvices — fetrt — wbe — stiH — r e quire more 
nursing hours than normal infants, and 
infants who require clos e obsop > 'ation for 
any r e ason. 

"N e onatal — interm e diat e — eafe — s e rvices" 
m e ans thos e services — provid e d by an 
acut e car e hospital to siok infants who do 
not r e quire n e onatal int e nsiv e care but 
who do — r e quir e six to twelve nursing 
hours p e r day. 

"N e onatal intensiv e car e s e rvices" means 
thos e s e rvices provided by an acut e care 
hospital — te — sev e rely — iH — infants — wbe 
r e quir e constant nursing car e , as well as 
continuous cardiopulmonary and other 
supportive car e . — N e onatal intensiv e care 
difF e rs from n e onatal int e rm e diate care 
with — regard — te — the — complexity' — &e 
multiplicity' of patient problems, e.g. care 
r e quir e d for n e onatal surg e ry' pati e nts. 
"N e onatal services" — means any of th e 
s e rvic e s defin e d in this Rule. 



{4^ 



{§)- 



Statutory Authority G. S 131E-1 77(1). 

.1404 CAPACITY E^J THE FACILITY AND 
ESf THE HEALTH SERVICE AREA 

4a) — Proposals filed by or on b e half of hospital 
facilities for n e onatal services must be consist e nt 
with th e applicabl e North Carolina State M e dical 
Faciliti e s Plan, with th e applicable North Carolina 
Stat e Health Plan (the on e in e ff e ct at tim e of final 
ag e ncy d e cision), and with the applicable health 
syst e ms plan. 

{b) Proposals — involving — new — er — e xpand e d 

n e onatal bassin e ts/b e ds must specify' th e numbers 
of n e onatal bassin e ts/b e ds to be op e rat e d following 

th e completion of the propos e d proj e ct. Such 

sp e cification must b e in t e rms of normal newborn 
services. — neonatal — continuing — eafe — s e rvices. 



1020 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



neonatal int e rmodiat e ooro oorvio e s, and n e onatal 
intonoivo oaro oorvioes. If lovela of oar e oth e r than 
tbat — fep — normal — n e wborns — afe — involv e d, — tbe 
proponont must defin e tho manner in whioh the 
proponent d e oignatoo b e ds for auoh lovelo. 

•(e) — A proposal involving a n e t inor e os e in th e 
tetal — number — of a — faoility's — existing — n e onatal 
int e rm e diate oar e b e ds and n e onatal int e nsiv e oar e 
beds shall not be approv e d unless the overall 
averag e annual oooupanoy, — ov e r th e — 12 months 
immediat e ly — prec e ding — the — submittal — ef — the 
proposal, — ef — th« — functional — existing — n e onatal 
intermediate car e b e ds in the facility in whioh th e 
propos e d beds ar e to bo operat e d is at l e ast 8 
p e rc e nt. 

4d) He — proposal — fer — additional — n e onatal 

interm e diat e care or n e onatal intensiv e care beds 
shall b e approved unless it is d e t e rmin e d that an 
unm e t need exists in th e health servic e ar e a or in 
th e propon e nt's defin e d servic e ar e a in whioh the 

proposed b e ds ar e to b e op e rat e d. Need for 

n e onatal — interm e diate — eare — beds — asd — n e onatal 
intensive car e b e ds shall b e comput e d for e ach of 
the six established health service ar e as in North 
Carolina by: 

(4-) identifying the annual numb e r of liv e 

births occurring at all hospitals locat e d 
within the h e alth s e rvice ar e a, using th e 
latest available data compil e d by th e 
Division of Health Services; 

(3) identifying th e low birth w e ight rate 

(perc e nt — of live — births — below — 2500 
grams) for the births id e ntifi e d in (1) of 
tbis — Subparagraph, — using — the — latest 
available data compil e d by th e Division 
of Health Services; 



f^ 



dividing — the — lew — bifth — w e ight — Fate 
identifi e d in (2) of this Subparagraph by 
.0 8 and subs e qu e ntly multiplying the 
resulting quoti e nt by four; and 

{4) determining need for n e onatal intensive 

©are — beds — aed — n e onatal — intermed iate 
oar e b e ds in th e h e alth servic e ar e a as 
the product of: 
(A) — the product derived in — (3) of this 



m- 



Subparagraph, and 
-the — quoti e nt — resulting 



from — the 



division of the number of liv e births 
in th e initial y e ar of the proj e ction 
identified in (1) of this Subparagraph 
by th e numb e r 1000. 

Statutory Authority G.S. 131E-177(1). 

.1405 SCOPE OF SERVICES OFFERED 



{a) — A proposal to provide new normal newborn 
s e rvices or n e onatal continuing care services must 
docum e nt th e e xt e nt to which th e following V r 'ill be 
availabl e . — If any item will not be availabl e , then 
substantive information must b e given obviating 
tho need for that it e m b e fore appro^'al for a n e w or 
e xpand e d s e rvic e can b e giv e n: 

<4^ a — distinct, — id e ntifiable — area — for tho 

provision of the propos e d s e rvice; 

43) comp e t e nc e to manag e uncomplicated 

labor — asd — delivery — ef — normal — term 
n e wborn; 

4^) capability fef continuous fetal 

monitoring; 

(4) a — continuing — e ducation — program — ee 

r e suscitation — te — enhance — competence 
among all delivery room personnel in 

tb« imm e diat e e valuation aft4 

r e suscitation of th e n e wborn and of tho 
moth e r; 

(#) availability of obst e tric services; 

{6) capability for cesarean s e ction within 30 

minut e s at any hour; and 

f?) twenty four hour on call availability of 

blood, — anesth e sia — service, — radiology 
service, clinical laboratory service. 
(b) — A proposal to provide new or e xpanded 
n e onatal int e rm e diat e car e s e rvic e s or neonatal 
intensive care services must m e et the r e quirem e nts 
of (a) of this Rule as w e ll as docum e nt the extent 
to whioh th e following will be available. — If any 
itofH — wiH — net — be — available, — then — s ub s tantive 
information must be given obviating the need for 
that it e m b e fore approval for a n e w or e xpanded 
service can be given: 

-a — distinct, — identifiable — area — for — the 



k^ 

provision of th e proposed sorvioo; 
{3) compet e nce — te — manag e — labor — and 

d e livery of pr e matur e n e wborns and 

newborns with complications; 
{5) twenty four hour coverag e »f 

microchemistry h e matology and blood 

gas e s; 
f4) twenty four hour coverag e by 

respiratory therapy; 
{5) tw e nty four hour coverage with 

portable radiographic capability; 
-Q; /air/suction capability'; 

e lectronic cardiovascular ft»d 



6^ 



respiration monitoring capability; 
capabilities for e ndotracheal intubation 



48)- 



and m e ohanical ventilator^' assistanc e ; 
oardio r e spirator^' — arr e st — management 
plan. 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1021 



PROPOSED RULES 



Statutory Authority G.S. 131E-177(1). 

.1406 PROJECTED UTILIZATION/ 
OCCUPANCY 

(a) — Propon e ntB proposing new normal n e wborn 
and neonatal continuing oare oervio e s must p e r 
form, or proj e ot to p e rform, at looot 500 d e liv e r 
ioo, p e r year e xc e pt that a varianoo from this 
standard will b e allowed to th e e xt e nt that a sub 
stantial portion of th e population to b e s e rv e d 
resid e more than 4 5 minut e s automobile driving 
time (on e v i py) from e xisting inpati e nt noonatol 
s e rvio e o. 

{b) — A propo s al to provid e n e w normal n e wborn 
or n e onatal continuing oare o e rvio e s. or n e w or 
e xpand e d interm e diat e care oervio e s or n e onatal 
intensiv e oar e service s , or any combination of th e 
four muot projeot an ocoupanoy level for each of 
the servic e s for each of th e first e ight calendar 
quartero following the compl e tion of the propooed 
proj e ot. — All assumptions, including the sp e oifio 
methodologies by whioh oooupancies ar e proj e ct e d, 
must be clearly stat e d. 

{&) — A proposal to provide new normal newborn 
and n e onatal continuing care oervioes shall not b e 
approv e d — unl e ss — for th e total — numb e r of b e ds 
propos e d to — be operat e d annual — occupancy — ts 
proj e ct e d to be 50 p e rc e nt. Occupancy i o proj e ct e d 
to be 60 perc e nt for a 1 10 b e d unit, 65 p e rcent 
for a 11 20 b e d unit. 70 p e rcent for a 21 30 b e d 
unit, and 75 p e rc e nt for a unit of 31 b e ds or mor e 
after two years foUowmg th e completion of the 
propos e d proj e ct. — All a ss umptions, including th e 
sp e oifio methodologi e s by whioh occupancies are 
proj e ct e d, must b e cl e arly stat e d. 

fd) — A proposal to provide new n e onatal inter 
m e diat e car e services or new neonatal intensiv e 
car e s e rvices shall not b e approved unless ocou 
panoy is proj e ct e d to b e at least 75 p e rc e nt for th e 
total numb e r of n e onatal int e rm e diat e care b e ds 
and n e onatal intensive oar e b e ds proposed to b e 
op e rat e d, no lat e r than three years following th e 
compl e tion of the propo s ed proj e cts. — All assump 
tions, — mcluding — th e s p e cific — m e thodologi e s — by 
which occupancies ar e project e d, must b e clearly 
stat e d . 

Statutory Authority G.S 131 E-1 77(1). 



s e rvic e by poroontag e by oounty of r e sidonoo. — AH 
assumptions, including th e speoifio methodology 
by which pati e nt origin is projootod. — must be 
ol e arly stat e d. 

{b) — A proposal to provide now normal n e wborn 
or n e onatal continuing car e servic e s must doou 
m e nt that at least 90 p e rc e nt of th e anticipated 
patient population is within 4 5 minutes driving 
tim e (one way) from th e facility. 

(e) — A proposal to provide now or e xpand e d 
neonatal — int e rm e diat e oare sorvioos — or new or 
e xpand e d n e onatal — int e nsiv e car e s e rvicoo — mu s t 
docum e nt that at l e ast 90 p e rc e nt of tho anticipated 
pati e nt population is within 90 minut e s driving 
tim e (on e v . oy) from th e facility', with tho oxcop 
tion that ther e may b e a varianc e from the 90 
p e rc e nt standard for institutions with very sp e cial 
iz e d lev e ls of n e onatal care to a largo and goo 
graphically div e rs e population. 

Statutory Authority G.S 131 E-1 77(1). 

.1408 SITE AND EQUIPMENT 

A proposal to provide new or e xpanded neonatal 
s e rvices must provid e docum e ntation to show that 
th e s e rvic e s will be ofiFered in a physical environ 
ment that conforms to the r e quir e m e nt!) of federal, 
state, and local r e gulator^' bodi e s. 

Statutory Authority G.S 131E-177(1). 

.1409 STAFFING 

(a) A propo s al to offer n e w or e xpanded ncona 
tal servic e s must provid e docum e ntation to s how 
that th e appropriate typ e s and numbers of staff, 
particularly qualifi e d m e dical and nursing staff", 
will b e availabl e to support the servicoo. 

{b) — A proposal to off^ e r new or expand e d n e ona 
tal interm e diate car e or neonatal int e nsiv e car e 
services must provide documentation to show that 
such servic e s will: 

^4^ b e coordinat e d by a regist e r e d nurs e 

who has completed an organiz e d e duoa 
tional program in neonatal int e rm e diat e 
and inten s ive care, and 

(3) b e und e r th e dir e ction of a physician 

with training and exp e ri e nce in neonatal 
int e rm e diat e and int e nsive care. 



.1407 PROJECTED PATIENT ORIGIN 

(a) — A proposal to provid e n e w normal n e wborn 
or n e onatal continuing car e s e rvic e s, or n e w or 
expand e d int e rm e diat e car e servic e s or n e onatal 
int e nsiv e car e services, or any combination of th e 
four must proj e ct pati e nt origin for e ach propos e d 



Statutory Authority G.S 131 E-1 77(1). 

.1413 DEFINITIONS 

The definitions in this Rule shall apply to all 
rules in this Section: 
( 1) "Approved neonatal service" means a 



1022 



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September 15, 1993 



PROPOSED RULES 



I2i 

i21 



14} 



15} 



neonatal service that was not operational 
prior to the beginning of the review 
period but that had been issued a 
certificate of need or for which 
development had been initiated prior to 
March 18. 1993 in accordance with G.S. 
131E-175. et. al. 
"Existing neonatal service" means a 



16} 



neonatal service in operation prior to the 
beginning of the review period. 
"High-risk obstetric patients" means 
those patients requiring specialized 
services provided by an acute care 
hospital to the mother and fetus during 
pregnancy, labor, delivery and to the 
mother after delivery. The services are 
characterized by specialized facilities and 
staff for the intensive care and 
management of high-risk maternal and 
fetal patients before and during delivery. 
"Level I neonatal service" means those 
routine services provided by an acute 
care hospital to normal full -term and pre- 
term infants weighing at least 2000 grams 
at birth. Level I neonatal services 
include the observation, screening, and 
stabilization of: infants following birth 
who are served in a bassinet; infants who 
are not sick but who require special care 
and frequent feedings; infants who no 
longer require Level II or Level III 
neonatal services, but who still require 
more nursing hours than normal infants; 
and infants who require close observation 
in a licensed acute care bed. 
"Level II neonatal service" means the 
performance of Level I neonatal services, 
plus the management of high-risk, small, 
and sick neonates with a moderate degree 
of illness that are admitted within the 
hospital or transferred from another 
facility. Level II neonatal services 
involve the management of newborns 
weighing between approximately 1,500- 
2,500 grams (or approximately 32 and 
less than 36 completed weeks of 
gestational age) that are relatively 
healthy, or involve intermediate care 
services for sick infants who do not 
require intensive care but who do require 
six to twelve nursing hours per day. 
Level II neonatal services are provided in 
a licensed acute care bed. 
"Level III neonatal service" means the 
performance of Level I and Level U 



m 

£8} 

£9} 
(10) 



neonatal services plus the management of 
high-risk newborns weighing less than 
1,500 grams (or approximately under 32 
weeks of gestational age), which requires 
neonatal expertise. Level III neonates 
require constant nursing care, including 
but not limited to continuous 
cardiopulmonary and other supportive 
care, care required for neonatal surgery 
patients and other intensive care services. 
Level III neonatal services are provided 
in a licensed acute care bed. 
"Neonatal intensive care services" is 
defined in G.S. I31E-I76(15b). 
"Neonatal service area" means a 
geographic area defined by the applicant 
from which the patients to be admitted to 
the service will originate. 
"Neonatal services" means any of the 
Level L Level II or Level III services 
defined in this Rule. 

"Obstetric services" means any normal or 
high-risk services provided by an acute 
care hospital to the mother and fetus 
during pregnancy, labor, delivery and to 
the mother after delivery. 
"Perinatal services" means services 
provided during the period shortly before 
and after birth. 

"Perinatal regions" mean a geographic 
area of the state as established by the 
Perinatal Council. A copy of the 
perinatal regions may be obtained from 
the Division of Maternal and Child 
Health, Department of Environment, 
Health and Natural Resources, 1330 St. 
Mary's Street, Raleigh. NC. 27605-3248. 



Statutory Authority G.S. 131E-177(1). 

.1414 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing to develop a new 
neonatal service or to add a bed to an existing 
neonatal service shall use the Acute Care 
Facility/Medical Equipment application form. 

(b) The applicant shall provide the following 
additional information: 

(1 ) the current number of Level I bassinets. 
Level I beds. Level H beds and Level 
III beds operated by the applicant; 

(2) the proposed number of Level I 
bassinets. Level I beds. Level H beds 
and Level III beds to be operated 
following completion of the proposed 



nil 



12} 



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September 15, 1993 



1023 



PROPOSED RULES 



project; 

(3) evidence of the applicant's experience 
in treating the following patients at the 
facility during the past twelve months, 
including: 

(A) the number of obstetrical patients 
treated at the acute care facility; 

(B) the number of neonatal patients 
treated in Level I bassinets. Level I 
beds. Level II beds and Level III 
beds, respectively; 

(C) the number of inpatient days at the 
facility provided to obstetrical 
patients; 

(D) the number of inpatient days provided 
in Level I beds. Level U beds and 
Level III beds, respectively; 

(E) the number of high-nsk obstetrical 
patients treated at the applicant's 
facility and the number of high-risk 
obstetrical patients referred from the 
applicant's facility to other facilities 
or programs; and 

(F) the number of neonatal patients 
referred to other facilities for 
services, identified by required level 
of neonatal service (i.e. Level ]_, 
Level II or Level III); 

(4) the projected number of neonatal 
patients to be served identified by Level 
L Level II and Level III neonatal 
services and by county of residence for 
each of the first twelve quarters of 
operation following the completion of 
the project, including the methodology 
and assumptions used for the 
projections; 

(5) the projected utilization of the Level I 
bassinets. Level I beds. Level H beds 
and Level III beds, respectively, by 
county of residence for each of the first 
twelve quarters of operation following 
completion of the project, including the 
methodology and assumptions used for 
the projections; 

(6) if proposing to provide Level I neonatal 
services, documentation that at least 90 
percent of the anticipated patient 
population is within 45 minutes driving 
time one-way from the facility; 

(7) if proposing to provide Level ] neonatal 
services, documentation of a written 
plan to transport infants to Level II or 
Level III neonatal services as the 
infant's care re<quires; 



181 



19} 



(10) 



an 



12) 



if proposing to provide Level U or 
Level III neonatal services, 
documentation that at least 90 percent 
of the anticipated patient population is 
within 90 minutes driving time one-way 
from the facility, with the exception 
that there shall be a variance from the 
90 percent standard for facilities which 
demonstrate that they provide very 



specialized levels of neonatal care to a 
large and geographically diverse 
population, or facilities which 
demonstrate the availability of air 
ambulance services for neonatal 
patients; 

evidence that existing and approved 
neonatal services and obstetric services 
in the applicant's perinatal region and 
in the applicant's defined neonatal 
service area are unable to accommodate 



the applicant's projected need 
additional Level I] and Level 
services; 



for 
III 



IB) 
IQ 
ID] 

ID 



IF] 
(13) 



documentation of the availability of 
existing obstetric services, and the 
identification of ajj obstetrics programs 
and neonatal services which currently 
serve patients from the applicant's 
primary service area; 
an analysis of the proposal's impact 
upon existing and approved neonatal 
services in the same perinatal region(s) 
and those perinatal regions adjacent to 
the perinatal region(s) in which the 
applicant proposes to provide services, 
including but not limited to the 
proposal's effect on the utilization of 
existing neonatal services, except when 
an applicant demonstrates that they 
provide very specialized levels of 
neonatal care to a large and 
geographically diverse population; 
evidence that the applicant shall have 
access to a transport service with at 
least the following components: 

trained personnel; 

transport incubator; 

emergency resuscitation equipment; 

oxygen supply and the means of 

administration; 

portable cardiac and temperature 

monitors; and 

a ventilator; 



documentation that the new or 
additional neonatal service shall be 



1024 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



iM 



£B} 

im 

£F} 
(14) 



coordinated with the existing statewide 
perinatal network, including but not 
limited to: 

the Division of Maternal and Child 

Health of the Department of 

Environment, Health and Natural 

Resources, 

the physicians' statewide neonatal bed 

locator system, 

existing neonatal services, 

existing obstetrical services, 

home health care agencies, 

other hospitals, and 

local Departments of Social Services; 
copies of written policies which provide 
for parental participation in the care of 
their infant, as the infant's condition 

family 
care 



(15) 



permits, in order to facilitate 
adjustment and continuity of 
following discharge: and 
copies of written policies 



and 



£A} 

Hi 
ID} 



{c} An 
additional 
following: 

m 



oi 



m 

141 
(51 



procedures regarding the scope and 
provision of care within the neonatal 
service, including but not limited to the 
following: 

the admission and discharge of 

patients; 

infection control; 

pertinent safety practices; and 

the triaging of patients requiring 

consultations, including the transfer of 

patients to another facility, 
applicant proposing to provide new or 
neonatal services shall provide the 

documentation that the proposed service 
shall be operated in an area organized 
as a physically and functionally distinct 
entity with controlled access; 
documentation to show that the new or 
additional Level I^ Level II or Level III 
neonatal services shall be offered in a 
physical environment that conforms to 
the requirements of federal , state, and 
local regulatory bodies; 
a detailed floor plan of the proposed 
area drawn to scale; 
documentation of direct or indirect 
visual observation by unit staff of all 
patients from one or more vantage 
points; and 

documentation that the floor space 
allocated to each bed and bassinet shall 
accommodate equipment and personnel 
to meet anticipated contingencies. 



Statutory Authority G.S. ] 31 E- 177(1). 

.1415 REQUIRED PERFORMANCE 
STANDARDS 

(a) An applicant shall demonstrate that the 
proposed project is capable of meeting the 
following standards: 

(1) applicants proposing new or additional 
Level I services shall perform or 
project to perform, at least 500 
deliveries per year, except that a 
variance from this stendard shall be 
allowed to the extent that a major 
portion of the population to be served 
reside more than 45 minutes automobile 
driving time one-way from existing 
inpatient neonatal services; 

(2) applicants proposing new or additional 
Level I services shall demonstrate that 
the following standards will be met: 

(A) the occupancy of the a pplicant's tofal 
number of neonatal beds is projected 
to be 50% or more during the first 
year of operation following 
completion of the proposed project- 
Provide all assumptions and data 
supporting the methodology used for 
the projections; 

(B) if an applicant is proposing additional 
Level I services and does not 
currently provide Level II or Level III 
services, the projected occupancy of 
the proposed service shall be at least 
75% after the second year of 
operation following completion of the 
proposed project and provide all 
assumptions and data supporting the 
methodology used for the projections; 

(C) if an applicant is proposing additional 
Level I services and currently 
provides Level II or Level III 
services, the projected occupancy of 
all neonatal services in the facility 
shall be at least 65% after the second 
year of operation following 
completion of the proposed project, 
and provide all assumptions and data 
su pporting the methodology used for 
the projections; 

the total number of Level I neonatal 
bassinets and Level I neonatal beds 
projected to be operated in the facility 
shall exceed the number of obstetric 
beds in the facility by at least 25%; 
and 



£D} 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1025 



PROPOSED RULES 



lEi 



ill 



(4) 



the total number of Level I neonatal 

bassinets and Level I neonatal beds 

projected to be operated in the facility 

shall exceed the number of obstetric 

beds in the facility by at least 35% if 

Level n or Level 111 services will be 

provided in the facility; 

if an a pplicant proposes an increase in 

the number of the facility's existing 

Level II or Level III beds, the overall 

average annual occupancy of the total 

number of existing Level II and Level 

III beds in the facility is at least 75%. 

over the \2 months immediately 

preceding the submitfal of the proposal; 

and 

if an applicant is proposing to develop 

a new or additional Level II or Level 

III beds, the projected occupancy of the 

total number of Level II and Level III 

beds proposed to be operated after the 

second year of operation of the 

proposed project shall be at least 75%. 

The applicant shall document the 

assumptions and provide data 

supporting the methodology used for 

the projections. 

(b) If an applicant proposes to develop a new 

Level II or Level III service the applicant shall 

document that an unmet need exists in the perinatal 

region or in the applicant's defined neonatal 

service area. The need for Level II and Level III 

beds shall be computed for each of the perinatal 

regions in North Carolina or in the applicant's 

neonatal service area by: 

(1) identifying the annual number of live 
births occurring at all. hospitals within 
the perinatal region or proposed 
neonatal service area, using the latest 
available data compiled by the State 
Center for Health and Environmental 
Statistics; 

(2) identifying the low birth weight rate 
(percent of live births below 2.500 
grams) for the births identified in £1J of 
this Paragraph. using the latest 
available date compiled by the State 
Center for Health and Environmental 
Statistics; 

(3) dividing the low birth weight rate 
identified in (2) of this Paragraph by 
■08 and subsequently multiplying the 
resulting quotient by four; and 

(4) determining the need for Level II and 
Level III beds m the perinatal region or 



proposed neonatal service area as the 
product of: 

(A) the product derived in £3) of this 
Paragraph, and 

(B) the quotient resulting from the 
division of the number of live births 
in the initial year of the determination 
identified in OJ of this Paragraph by 
the number 1000. 

Statutory Authority G.S. 131E-177(1). 

.1416 REQUIRED SUPPORT SERVICES 

(a) An applicant proposing to provide new or 
additional Level f. Level II or Level III services 
shall document that the following items shall be 
available, unless an item shall not be available, 
then documentation shall be provided obviating the 
need for that item: 



m 

121 
ID 



competence to manage uncomplicated 
labor and delivery of normal term 
newborn; 

capability for continuous fetal 
monitoring; 

a continuing education program on 
resuscitation to enhance competence 
among all delivery room personnel in 
the immediate evaluation and 
resuscitation of the newborn and of the 
mother; 

obstetric services; 
anesthesia services; 

capability of cesarean section within 30 
minutes at any hour of the day; and 
twenty-four hour on-call blood bank, 
radiology, and clinical laboratory 
services. 
(b) An applicant proposing to provide new or 
additional Level II or Level III services shall 
document that the following items shall be 
available, unless any item shall not be available, 
then documentation shall be provided obviating the 
need for that item: 

labor 



£41 
(5) 
(6) 

ill 



12} 

£3} 

14] 

15} 
£6} 



competence to manage 



and 



delivery of premature newborns and 

newborns with complications; 

twenty-four hour availability of 

microchemistry hematology and blood 

gases; 

twenty-four hour coverage by 

respiratory therapy; 

twenty-four hour radiology coverage 

with portable radiographic capability; 

oxygen and air and suction capability; 

electronic cardiovascular and 



1026 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



respiration monitoring capability; 

(7) vital sign monitoring equipment which 
has an alarm system that is operative at 
all times; 

(8) capabilities for endotracheal intubation 
and mechanical ventilatory assistance; 

£9} cardio-respiratory arrest management 
plan; 

(10) isolation capabilities; 

(11) social services staff; 

(12) occupational or physical therapies with 
neonatal expertise; and 

(13) a registered dietician or nutritionist with 
training to meet the special needs of 
neonates. 

(c) An applicant proposing to provide new or 
additional Level III services shall document that 
the following items shall be available, unless any 
item shall not be available, then documentation 
shall be provided obviating the need for that item: 
(1) pediatric surgery services; 

ophthalmology services; 

pediatric neurology services; 

pediatric cardiology services; 

on-site laboratory facilities; 

computed tomography and pediatric 

cardiac catheterization services; 

emergency diagnostic studies available 

24 hours per day; 

designated social services staff; and 

serve as a resource center for the 



13} 
£41 
15} 
£6} 

01 



(81 
19} 



statewide perinatal network. 



Statutory Authority G.S. 131E-177(1). 

.1417 REQUIRED STAFFING AND STAFF 
TRAINING 

An applicant shall demonstrate that the following 
staffing requirements for hospital care of newborn 
infants shall be met: 

(1) If proposing to provide new or additional 
Level I services the applicant shall 
provide documentation to demonstrate 
that: 

(a) the nursing care shall be supervised by 
a registered nurse in charge of perinatal 
facilities; 

(b) a physician is designated to be responsi- 
ble for neonatal care; and 

(c) the medical staff will provide physician 
coverage to meet the specific needs of 
patients on a 24 hour basis. 

(2) If proposing to provide new or additional 
Level II services the applicant shall pro- 
vide documentation to demonstrate that: 



(a) the nursing care shall be supervised by 
a registered nurse with educational 
preparation and advanced skills for 
maternal-fetal and neonatal services; 

(b) the service shall be stafFed by a board 
certified pediatrician with certification, 
special interest, experience, or training 
in neonatology; and 

(c) the medical staff will provide physician 
coverage to meet the specific needs of 
patients on a 24 hour basis. 

(3) If proposing to provide new or additional 
Level III services the applicant shall 
provide documentation to demonstrate 
that: 

(a) the nursing care shall be supervised by 
a registered nurse with educational 
preparation and advanced skills for 
maternal-fetal and neonatal services; 

(b) the service shall be staffed by a full- 
time board certified pediatrician with 
certification in neonatal medicine; and 

(c) the medical staff will provide physician 
coverage to meet the specific needs of 
patients on a 24 hour basis. 

(4) All applicants shall submit documentation 
which demonstrates the availability of 
appropriate inservice training or continu- 
ing education programs for neonatal staff. 

(5) All applicants shall submit documentation 
which demonstrates the proficiency and 
ability of the nursing staff in teaching 
parents how to care for neonatal patients 
following discharge to home. 

(6) All applicants shall submit documentation 
to show that the proposed neonatal ser- 
vices will be provided fn conformance 
with the requirements of federal . state 
and local regulatory bodies. 

Statutory Authority G.S. 131E-]77(1). 

.1418 DATA REPORTING REQUIREMENTS 

The facility shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information, m accor- 
dance with data format and reporting requirements 
formulated by the Division of Facility Services: 

(1) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S 131E-177(1). 
.1419 ACCESSIBILITY 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1027 



PROPOSED RULES 



(a) The applicant shall provide documentation 
describing the mechanism that shall be used to 
insure that the projected number of medically 
underserved shall be served in the unit. 

(b) The applicant shall provide a copy of the 
written admissions policies identifying any prepay- 
ment or deposit requirements for the facility and 
stating the admissions requirements for each of the 
following payor categories: 



m 

121 
£3} 
14] 
15) 
(6} 



Medicare; 

Medicaid; 

Blue Cross and Blue Shield; 

Commercial Insurance; 



indigent 



17} 



State Employees Health Plan; 
Self-Pay (includes self-pay, 
and charity care) ; and 
Other as identified by the applicant. 

(c) The applicant shall provide a written descrip- 
tion of the billing procedures, including the credit 
collection policies, that shall be utilized by the 
facility. 

(d) The applicant shall document that the health 
care community in the applicants neonatal service 
area, including the Departments of Social Services 
and Health, have been invited to comment on the 
proposed project, particularly with regard to the 
facility's referral mechanisms and admissions 
policies for the medically underserved. 

Statutory Authority G.S. 1 31 E- 1 77(1). 

SECTION .1600 - CRITERIA AND 

STANDARDS FOR CARDIAC 

CATHETERIZATION EQUIPMENT AND 

CARDIAC ANGIOPLASTY EQUIPMENT 

.1613 DEFINITIONS 

The following definitions wiH shall apply to all 
rules in this Section: 

(1) "Approved" means the equipment was 
not in operation prior to the beginning of 
the review period and had been issued a 
certificate of need or had been acquired 
prior to March 18, 1993 in accordance 
with G.S.I3IE-175, et. al. 

(2) fB "Capacity" of a an item of cardiac 
catheterization room equipment or cardi- 
ac angioplasty equipment is consider e d to 
be lOOQ means 1270 diagnostic-equiva- 
lent procedures per year. One PTCA 
therapeutic cardiac catheterization proce- 
dure is valued at twe 1 .67 diagnostic- 
equivalent procedures. One p e diatric 
cardiac catheterization procedure per- 
formed on a patient age five or under is 



valued at two diagnostic-equivalent pro- 
cedures. All other procedures are valued 
at one diagnostic-equivalent procedure. 

(3) "Cardiac angioplasty equipment" is de- 
fined in G.S.131E-176(2e). 

(4) (3) "Cardiac catheterization" is means a 
diagnostic, electrophysiology or therapeu- 
tic procedure performed using cardiac 
catheterization equipment or cardiac 
angioplasty equipment in a cardiac cathe- 
terization room, whereby a flexible tube 
is inserted into the patient's body , usually 
through an extremity blood veoa e l, and 
advanced und e r — fluorosoopio — guidance 
into the heart chambers to perform a 
hemodynamic or angiographic examina- 
tion or therapeutic intervention of the left 
and or right heart chamber, or coronary 
arteries-; — therapeutic — int e rvention — m — a 
coronary art e ry' may also be p e rformed 
using oardiao cath e t e rization. By thi s 
d e finition a cardiac catheterization procc 
dure does not includ e a simpl e right heart 
cath e t e rization for monitoring purpos e s as 
might b o don e in an el e ctrophysiology 
laboratory, pulmonary angiography as an 
isolat e d — proc e dure, — &f — cardiac — pacing 

through a right e l e ctrode catheter. k 

do e s includ e angiographic proc e dur e s to 
e valuate th e coronary' art e ri e s, and aortic 
root inj e ctions to e xamine th e degr e e of 
aortic regurgitation or deformity of aortic 
valv e . 

(5) "Cardiac catheterization equipment" is 
defined in G.S. 131E-176(2f). 

(6) (^ "Cardiac catheterization procedure" 
means a single episode of diagnostic, 
electrophysiology or therapeutic catheter- 
ization which occurs during one visit to a 
cardiac catheterization room. 

(7) (4) "Cardiac catheterization room" means 
a room in a hospital or a mobile unit in 
which has th e there is cardiac catheteriza- 
tion or cardiac angioplasty equipment 
r e quir e d — te — p e rform — angiographic — and 
phy s iologic for the provision of cardiac 
catheterization proc e dure s , and which has 
b e en approv e d by th e C e rtificat e of Need 
S e ction as a cardiac catheterization room 
services . 

(8) fl-B " Cardiac catheterization Sservice 
area" means a geographical area defined 
by the proponent applicant , which has 
boundaries that are not farther than 90 
road miles from the facility, if the facility 



1028 



8:12 



NORTH CAROLINA REGISTER 



September 15. 1993 



PROPOSED RULES 



has a comprehensive cardiac services 
program; and not farther than 45 road 
miles from the facility if the facility 
performs only diagnostic cardiac 
catheterization procedures. 
£9} "Cardiac catheterization services" means 
the provision of diagnostic cardiac 
catheterization procedures, therapeutic 
cardiac catheterization procedures or 
electrophvsiology catheterization 
procedures. 

(10) {§) "Comprehensive cardiac services 
program" means a cardiac services 
program which provides the full range of 
clinical services associated with the 
treatment of cardiovascular disease 
including community outreach, 
emergency treatment of cardiovascular 
illnesses, non-invasive diagnostic imaging 
modalities, diagnostic and interv e ntional 
therapeutic cardiac catheterization 
procedures , open heart surgery and 
cardiac rehabilitation services. 
Community outreach and cardiac 
rehabilitation services menf shall be 
provided by the applicant or through 
arrangements with other agencies and 
fecilities located in the same city. All 
other components of a comprehensive 
cardiac services program must shall be 
provided within a single facility. 

(11) (6) "Diagnostic cardiac catheterization 
procedure" means a cardiac 
catheterization procedure performed 
using cardiac catheterization or cardiac 
angioplasty equipment for the purpose of 
detecting and identifying defects or 
diseases in the great arteries or veins of 
the heart, or abnormalities in the heart 
structure. 

■f^ "Expand e d cardiac cath e t e rization 

servic e " means th e addition or conv e rsion 
of a room to b e d e dicat e d to oardiao 

cath e terization proc e dures; ef the 

purchas e ef additional e quipm e nt 

specially — designed — te — p e rform — cardiac 
cath e terizations. 

(12) " Elect rophysio logy catheterization 
procedure" means a diagnostic or 
therapeutic cardiac catheterization 
procedure performed to study the 
electrical conduction activity of the heart 
and characterization of atrial ventricular 
arrhythmias utilizing cardiac 
catheterization equipment or cardiac 



(13) 
(14) 



(15) 



{«^ 



(16) 



(17) 



(18) 



angioplasty equipment. 

"Existing" means the equipment was in 

operation prior to the beginning of the 

review period. 

"High-risk patient" means a person with 

reduced life expectancy because of left 

main or multi-vessel coronary artery 

disease, often with impaired left 

ventricular function and with other 

characteristics as 

American 



referenced in 
e g e 



o 



1 1 



the 

oj 

Cardiology/ American Heart Association 
Guidelines for Cardiac Catheterization 
and Cardiac Catheterization Laboratories 
(1991) report. 

"Mobile equipment" means cardiac 
angioplasty equipment 



catheterization 



or cardiac 
equipment and 



transporting equipment which is moved 

to provide services at two or more host 

facilities. 

"P e diatric cardiac catheterization 



procedure" mean s a cardiac 

catheterization proc e dur e perform e d on a 
pati e nt ag e five or under. 
(9) "Percutaneous transluminal coronary 
angioplasty (PTCA)" is a interv e ntional 
one type of therapeutic cardiac 
catheterization procedure used to treat 
coronary artery disease in which a 
balloon-tipped catheter is placed in the 
diseased artery and then inflated to 
compress the plaque blocking the artery. 
{40) "Primary cardiac catheterization 
service area" means a geographical area 
defined by the propon e nt applicant . 



which has boundaries that are not farther 
than 45 road miles from the facility, if 
the facility has a comprehensive cardiac 
services program; and not farther than 23 
road miles from the facility if the facility 
performs only diagnostic cardiac 
catheterization procedures. 
"Therapeutic cardiac catheterization 
procedure" means a cardiac 
catheterization procedure performed for 
the purpose of treating or resolving 
certain anatomical or physiological 
conditions which have been determined to 
exist in the heart or great arteries or 
veins of the heart. 

Statutory Authority G.S. 1 31 E- 177(1). 

.1614 INFORMATION REQUIRED OF 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1029 



PROPOSED RULES 



APPLICANT 

(a) An applicant that proposes a — sew — ef 
expand e d cardiac cath e t e rization servic e to acquire 
cardiac catheterization or cardiac angioplasty 
equipment must provid e th e information r e quested 
eft shall use the acute care facility/medical 
equipment application form. 

(b) In addition to information requested on the 
aouto car e application form, th e The applicant must 
shall provide the following additional information 
based on the population residing within the 
applicant's proposed cardiac catheterization service 
area : 

(1) the projected number of cardiac 
catheterization procedures, by CPT or 
ICD-9-CM by ty^ classification of 
cardiac catheterization procedure^ to be 
compl e t e d performed in each cardiac 
catheterization room for each of the 
first 12 calendar quarters following 
completion of the proposed project, 
including the methodology and 
assumptions used for these projections; 

(2) documentation of the applicant's 
experience in treating cardiovascular 
patients at the facility during the past 
twelve months, including; 

(A) the number of patients receiving stress 
tests; 

(B) the number of patients receiving 
intravenous thrombylitio thrombolytic 
therapies; 

(C) the number of patients presenting in 
the Emergency Room or admitted to 
the hospital with suspected or 
diagnosed acute myocardial inferction; 
and 

(D) the number of patients referred to 
other facilities for cardiac 
catheterization procedures and/or or 
open heart surgery procedures, by 
type of procedure; 

(3) the number of patients from the 
proposed service area who are projected 
to receive cardiac catheterization 
services by patient's county of 
residence in each of the first 12 
quarters of operation, including the 
methodology and assumptions used for 
these projections; 

(4) the number of patients from the 
proposed primary service area who are 
projected to receive cardiac 
catheterization services by patient's 
county of residence in each of the first 



12 quarters of operation, including the 
methodology and assumptions used for 
these projections; 

(5) documentation of the applicant's 
projected referral sources of patient* 
referrals that are located in the 
proposed service area, including letters 
from the referral sources that 
demonstrate their intent to refer patients 
to the applicant for cardiac 
catheterization services ; 

(6) evidence of the applicant's capability to 
communicate e fficiently with 
emergency transportation agencies and 
with an established comprehensive 
cardiac services program; 

(7) the number and composition of cardiac 
catheterization teams available to the 
applicant; 

(8) a brief description of documentation of 
the applicant's in-service training or 
continuing education programs for 
cardiac catheterization team members; 

(9) a written agreement with a 
comprehensive cardiac services 
program sp e cifying that specifies the 
arrangements for referral and transfer 
of patients seen by the proponent 
applicant which and that includes a 
process to alleviates the need for 
duplication in catheterization studies; 

( 10) a written description of patient selection 
criteria including referral arrangements 
for high-risk patientsrj 

(1 1) a copy of the contractual arrangements 
for the acquisition of the proposed 
cardiac catheterization equipment or 
cardiac angioplasty equipment, 
including itemization of the cost of the 
equipment; and 

(12) documentation that the cardiac 
catheterization equipment and cardiac 
angioplasty equipment and the 
procedures for operation of the 
equipment are designed and developed 
based on the American College of 
Cardiology/ American Heart Association 
Guidelines for Cardiac Catheterization 
Laboratories (1991) report. 

Statutory Authority G.S. 131E-177(1). 

.1615 REQUIRED PERFORiMANCE 
STANDARDS 

(a) To b e approv e d th e Stat e Ag e ncy must 



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PROPOSED RULES 



det e rmin e The a pplicant shall demonstrate that the 
project is capable of meeting the following 
standards: 

(1) each proposed item of cardiac 
catheterization room equipment or 
cardiac angioplasty equipment, 
including mobile equipment wiH shall 
be utilized at an annual rate of at least 
40 60 percent of capacity, measured 
during the fourth quarter of the third 
year following completion of the 
project; 

(2) if the facility applicant has — a 

compreh e nsiv e oardiao s e rvio e a 

program — ef — the — propon e nt — int e nds 
proposes to perform e l e ctiv e — PTCA 
therapeutic cardiac catheterization 
procedures, each of the propon e nt 
applicant's therapeutic cardiac 
catheterization teams will b e p e rforming 
shall be performing at an annual rate of 
at least 50 PTCA 100 therapeutic 
cardiac catheterization procedures, 
measur e d during the fourth quart e r of 
the third year of operation following 
completion of the project; 

(3) at least 50 percent of the projected 
cardiac catheterization procedures -wiH 
shall be performed on patients residing 
within the primary service area; 

(4) each existing item of cardiac 
catheterization room equipment and 
cardiac angioplasty equipment in each 
facility which has a primary service 
area that overlaps the proposed primary 
service area shall have been operated at 
a level of at least §0 80 percent of 
capacity during the 12 month period 
reflected in the most recent licensure 
form on file with the Division of 
Facility Services; 

(5) the utilization of each existing or 
approved item of cardiac catheterization 
programs equipment and cardiac 
catheterization angioplasty equipment 
whos e in each facility which has a 
primary service area that overlaps the 
proposed primary service area is not 
shall not be expected to fell below 40 
60 percent of capacity due to the 
institution — of th e — new or — e xpand e d 
program acquisition of the proposed 
cardiac catheterization, cardiac 
angioplasty, or mobile equipment : 

(6) if the applicant proposes to perform 



diagnostic cardiac catheterization 
procedures, th e applicant's — proj e ct e d 

utilization and proposed staffing 

patt e rns are suoh that each diagnostic 
cardiac catheterization team -wiH shall 
be performing at an annual rate of at 
least 150 diagnostic-equivalent 
catheterization procedures by the end of 
the third year following completion of 
the projectT i 

(7) each item of existing mobile equipment 
in the proposed cardiac catheterization 
service area shall have been performing 
at least an average of four diagnostic- 
equivalent catheterization procedures 
per day per site in the proposed cardiac 
catheterization service area in the 
twelve month period preceding the 
submittal of the application; and 

(8) each item of existing or approved 
mobile equipment to be operating in the 
proposed cardiac catheterization service 
area shall be performing at least an 
average of four diagnostic-equivalent 
catheterization procedures per day per 
site in the proposed cardiac 
catheterization service area in the 
applicant's third year of operation. 

(b) If the proponent intends applicant proposes 
to perform p e diatric cardiac catheterization 
procedures on patients age five and under , the 
State Ag e ncy must determine that th e proponent 
the applicant shall demonstrate that it meets the 
following additional criteria: 

(1) the fecility has the capability to perform 
both p e diatric diagnostic and 
therapeutic cardiac catheterization 
o e rvio e s procedures and p e diatric open 
heart surgery services on patients age 
five and under : 

(2) the proposed project wiH shall be 
performing at an annual rate of at least 
80 150 p e diatric cardiac catheterization 
procedures on patients age five or 
under during the fourth quarter of the 
third year following initiation of 
p e diatric the proposed cardiac 
catheterization service for patients age 
five and under . 

(c) An applicant shall provide documentation of 
all assumptions and data used in the development 
of the projections required in this Rule. 

Statutory Authority G.S. 131E-177(1). 



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1031 



PROPOSED RULES 



.1616 REQUIRED SUPPORT SERVICES 

(a) If the propon e nt int e nd B applicant proposes 
to perform e l e ctiv e PH'CA therapeutic cardiac 
catheterization procedures, th e Stat e Ag e noy must 
dotormino that th e propon e nt the applicant shall 
demonstrate that ha o aooo oo to — aft open heart 
surgery services are provided within the same 
facility. 

(b) If the applicant proposes to perform 
diagnostic cardiac catheterization procedures, the 
applicant shall document that its patients will have 
access to a facility which provides open heart 
surgery services, in close proximity, and that the 
patients can be transported to that facility with no 
greater risk than if the procedure had been 
performed in a hospital which provides open heart 
surgery services. 

(c) (b) To b e approved the Stat e Ag e noy must 
determin e The applicant shall provide 
documentation to demonstrate that the following 
services wtH shall be available in the facility: 

(1) electrocardiography laboratory and 
testing services including stress testing 
and continuous cardiogram monitoring; 

(2) echocardiography service; 

(3) blood gas laboratory; 

(4) pulmonary function unit; 

(5) sfaffed blood bank; 

(6) hematology laboratory/coagulation 
laboratory; 

(7) microbiology laboratory; 

(8) clinical pathology laboratory with 
facilities for blood chemistry; 
immediate endocardiac catheter 



121 



(10) 



pacemaking jn case of cardiac arrest; 

and 

nuclear medicine services including 

nuclear cardiology. 



Statutory Authority G.S. I31E-177(l). 

.1617 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) To b e approv e d, th e Stat e Ag e noy mu s t 
d e t e rmin e that th e propon e nt The applicant shall 
provide documentation to demonstrate that eafl 
m ee t the following staffing requirements shall be 
met: 

(1) one physician licensed to practice 
medicine in North Carolina who has 
been designated to serve as director of 
the cardiac catheterization service and 
who has all of the following special 
credentials: 
(A) board-certified in internal medicine, 



(B) 



(C) 



pediatrics or radiology; 
subspecialty training aad — board 
e ligibility' in cardiology, pediatric 
cardiology, or cardiovascular 
radiology; and 



current clinical experience in perform- 
ing physiologic procedures, 
angiographic procedures, or both; 
(2) at least one specialized team to perform 
cardiac catheterizations, composed of at 
least the following professional and 
technical personnel: 

(A) one physician licensed to practice 
medicine in North Carolina with 
evidence of special training and cur- 
rent experience in cardiovascular 
disease and radiation sciences; 

(B) one nurse with special training and 
current experience in critical care of 
cardiac patients, cardiovascular medi- 
cation, and catheterization equipment; 
and 

(C) at least three technicians with current 
specialized training in cardiac care 
who are capable of performing the 
duties of a radiologic technologist, 
cardiopulmonary technician, monitor- 
ing and recording technician, and 
darkroom technician. 

(b) To b e approv e d, the Stat e Ag e ncy must 
determin e that th e propon e nt The applicant shall 
provide documentation to demonstrate that eon 
provid e the following staff training shall be provid- 
ed for members of cardiac catheterization teams: 

(1) certification in cardiopulmonary resus- 
citation and advanced cardiac life sup- 
port; and 

(2) an organized program of staff education 
and training which is integral to the 
cardiac services program and ensures 
improvements in technique and the 
proper training of new personnel. 

Statutory' Authority G.S. 1 31 E- 1 77(1). 

.1618 DATA REPORTING REQUIREMENTS 

The facility must shall agree to provide^ upon the 
request of the Division of Facility Services, the 
following types of data and information to th e 
Division of Facility S e rvic e s , in accordance with 
data format and reporting requirements formulated 
by the Division of Facility Services: 

(1) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 



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PROPOSED RULES 



Statutory Authority G.S. 131E-177(1). 

.1619 ACCESSIBILITY 

(a) The applicant shall provide documentation 
describing the mechanism that will be used to 
ensure that the projected number of medically 
underserved will be served in the facility. 

(h) The applicant shall provide written 
admissions policies identifying any prepayment or 
deposit requirements for the facility and stating the 
admission requirements for patients in each of the 
following payor categories: 

(1) Medicare; 

(2) Medicaid; 

(3) Blue Cross and Blue Shield; 

(4) Commercial Insurance; 

(5) State Employees Health Plan; 

(6) Self- Pay (includes self-pay, indigent 
and charity care); and 

(7) Other as identified by the applicant. 

(c) The a pplicant shall provide a written 
description of the billing procedures, including the 
credit and collection policies that will be utilized 
by the facility. 

(d) The a pplicant shall document that the health 
care community in the service area, including the 
Departments of Social Services and Health, have 
been invited to comment on the proposed project, 
particularly with regard to the facility's referral 
mechanisms and admissions policies for the 
medically underserved. 

Statutory Authority G.S I31E-I77(1). 

SECTION .1700 - CRITERIA AND 

STANDARDS FOR OPEN-HEART 

SURGERY SERVICES AND HEART-LUNG 

BYPASS MACHINES 

.1713 DEFINITIONS 

The following definitions -wtH shall apply to all 
rules in this Section: 

(1) "Capacity" of an open heart ourgioal ouit e 
surgery room i s con s id e r e d to b e means 
400 adult-equivalent open heart surgical 
procedures per year. One p e diatric open 
heart surgical procedure on persons age 
5 and under is valued at two adult open 
heart surgical procedures. For purposes 
of determining capacity, one open heart 
surgical procedure is defined to be one 
visit or trip by a patient to the open heart 
surgical suite surgery room for an open 
heart operation. 

(2) "Cardiac Surgical Intensive Care Unit" 



m- 



means a distinct intensive care unit as 
defined in 10 NCAC 3R .1213(2) and 
which is for exclusive use by post- 
surgical open heart patients. 
"Expand e d — op e n — h e art — surgical — suit e " 
m e ans th e addition or oonv e roion of an 
op e rating room to b e d e dicat e d for open 
h e art surgical proc e dures. 

(3) "Heart-lung bypass machine is defined in 
G.S. 131E-176(10a). 

^ "Pediatric op e n h e art ourgioal proc e dure" 
means an op e n h e art ourgioal proc e dure 
p e rform e d on a pati e nt age five or und e r. 

(4) {9) " Open heart S e rvic e surgery service 
area" means a geographical area defined 
by the propon e nt applicant , which has 
boundaries that are not farther than 90 
road miles from the facility. 

(5) "Open heart surgery services" is defined 
in G.S. 131E-176(18b). 

(6) (^ "Open heart surgical procedures" 
means are — highly — op e oializod — surgical 
proo e dur e o — which — utiliz e a h e art lung 
bypaoo maohin e (th e "pump") to perform 

e xtra corpor e al circulation etn4 

oxyg e nation during surg e ry. — Op e n heart 
surgical proc e dureo includ e a wid e range 
of proc e dures those surgical procedures 
which are identified by Diagnostic 
Related Group ("DRG") numbers 104, 
105, 106, 107, and 108, and which are 
designed to correct congenital and 
acquired cardiac and coronary artery 
disease. 

£7} f4) "Open heart surgical suit e surgery 
room " means an operating room 
dedicated to open heart surgical 
procedures^ which has b ee n approv e d for 
this — use — by th e — C e rtificat e — ef — Need 
S e ction as reported on the most current 
hospital licensure application. , along with 
any r e lat e d rooms us e d for preparation 
and imm e diat e post operativ e recover)' of 
pati e nts r e ceiving an open heart surgical 
proc e dur e . 

(8) (6) "Open heart surgical surgery 
program" includ e s means all of the open 
heart surgical — suit e s surgery rooms 
operated in one hospital. 

fT) "Percutaneous — tran s luminal — coronary 

angioplasty (PTCA) proc e dur e " means an 

int e rv e ntional cardiac catheterization 

proc e dur e us e d to treat coronary artery 
dis e ase in which a balloon tipp e d catheter 
is plac e d in th e dis e as e d artery and th e n 



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1033 



PROPOSED RULES 



inflat e d to oompr e ss th e plaqu e blocking 
the art e r>'. 
(9) {^ "Primary open heart surgery service 
area" means a geographical area defined 
by the propon e nt applicant , which has 
boundaries that are not ferther than 45 
road miles from the facility. 

Statutory Authority G.S. 131E-177(1). 

.1714 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant that proposes a — new — ef 



e xpand e d to add an open heart surgiool — stHte 
surgery room or to acquire a heart-lung bypass 
machine must provid e th e information r e quested on 
shall use the acute care facility/medical equipment 
application form. 

(h) In addition to information r e qu e st e d on th e 
aouto oar e — application form, th e The applicant 
must shall also provide the following additional 
information: 

(1) the projected number of open heart 
surgical procedures to be completed in 
each open heart surgical suit e surgery 
room and the projected number of open 
heart surgical procedures to be 
performed on each heart-lung bypass 
machine for each of the first 12 
calendar quarters following completion 
of the proposed project, including the 
methodology and assumptions used 4ef 
to make these projections; 

(2) the projected number of cardiac 
catheterization procedures to be 
completed in the facility for each of the 
first 12 calendar quarters following 
completion of the proposed project, 
including the methodology and 
assumptions used for these projections; 

(3) the applicant's experience in treating 
cardiovascular patients at the facility 
during the past 12 months, including: 

(A) the number of patients receiving stress 
tests; 

(B) the number of patients receiving 
intravenous thrombolytic therapies; 

(C) the number of patients presenting in 
the Emergency Room or admitted to 
the hospital with suspected or 
diagnosed acute myocardial infarction; 

(D) the number of cardiac catheterization 
procedures performed, by type of 
procedure; 

(E) the number of patients referred to 



other facilities for cardiac 
catheterization or open heart sui^ical 
procedures, by type of procedure; 
(F) the number of patients referred to 
proponent's the applicant's facility for 
cardiac catheterization or open heart 
surgical procedures, by type of 
procedure; 

(4) the number of patients from the pro- 
posed open heart surgery service area 
who are projected to receive open heart 
surgical procedures by patient's county 
of residence in each of the first 12 
quarters of operation for those projco 
tions including the methodology and 
assumptions used to make the projec- 
tions ; 

(5) the number of patients from the pro- 
posed primary open heart surgery ser- 
vice area who are projected to receive 
open heart surgical procedures by 
patient's county of residence in each of 
the first 12 quarters, including the 
methodology and assumptions used -fef 
to make these projections; 

(6) the projected patient referral sources ef 
patients ; 

(7) evidence of the applicant's capability to 
communicate efficiently with emergen- 
cy transportation agencies and with all 
hospitals serving the proposed service 
area; 

(8) the number and composition of open 
heart surgical teams available to the 
applicant; 

(9) a brief description of the applicant's in- 
service training or continuing education 
programs for open heart surgical team 
members; and 

(10) evidence of applicant's the capability to 
perform both cardiac catheterization 
and open heart surgical procedures en 
a 24 hours per day, 7 days per week 

Statutory Authority G.S 13IE-177(1). 

.1715 REQUIRED PERFORMANC E 
STANDARDS 

To b e approv e d, th e State Agency must deter 
min e The applicant shall demonstrate that the 
proposed project is capable of meeting the follow- 
ing standardsTj^ 

(1) each open heart surgioal suit e surgery 
room mii shall be utilized at an annual 



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PROPOSED RULES 



rate of at least 50 percent of capacity, 
measured during the fourth twelfth quar- 
ter of th e third y e ar following completion 
of the project; 

(2) the propon e nt will b e performing a euffi 
oient number of applicant shall perform 
at least 4 diagnostic catheterizations te 
gen e rat e the proj e ct e d — numb e r of per 
open heart surgical proc e dur e s procedure 
during each quarter; 

0) the propon e nt will be p e rforming at an 

annual mto of at loaot 50 PTCA proo e 
duroD. m e asur e d during th e fourth quart e r 
of the third y e ar following compl e tion of 
the proj e ct; 

(3) a new or additional heart-lung bypass 
machine shall be utilized at 200 open 
heart surgical procedures per year, mea- 
sured during the twelfth quarter following 
completion of the project; 

(4) at least 50 percent of the projected open 
heart surgical procedures wiU shall be 
performed on patients residing within the 
primary open heart surgery service area; 

(5) each existing open heart ourgioal suit e 
surgery program in each facility which 
has a primary open heart surgery service 
area that overlaps the proposed primary 
open heart surgery service area operated 
at a level of a least 80 percent of capacity 
during the 12 month period reflected in 
the most recent licensure form on file 
with the Division of Facility Services; 

(6) the utilization of existing open heart 
surgical surgery programs whose primary 
open heart surgery service area overlaps 
the proposed primary open heart surgery 
service area is not expected to fall below 
50 percent of capacity due to the institu- 
tion of the new or expanded open heart 
surgical program; and surgery program; 

(7) the applicant's projected utilization and 
proposed staffing patterns are such that 
each open heart surgical team will b e 
performing shall perform at an annual 
rate of at least 150 open heart surgical 
procedures by the end of the third year 
following completion of the proj e ct. 
project; 

(8) the applicant shall document the assump- 
tions and provide data supporting the 
methodology used to make these projec- 
tions; and 

(9) heart-lung bypass machines that have 
been acquired for non-surgical use shall 



not be utilized in the performance of 
open heart surgical procedures. 

Statutory Authority G.S. 131 £-177(1). 

.1716 HOURS OF OPERATION 

To be approv e d, the Stat e Ag e ncy must d e t e r 
min e applicant shall d e monstrate that the proponent 
has th e capability of providing op e n h e art surgical 
proc e dur e s — 34 — houre — p e r day, — seven days — per 
w ee k. 

Statutory Authority G.S. 1 31 E- 177(1). 

.1717 REQUIRED SUPPORT SERVICES 

(a) To b e approv e d, th e Stat e Agency must 
d e t e rmin e The applicant shall demonstrate that the 
following services witt shall be available on a in 
the facility 24 hours per day, 7 days per week 
basis in the facility : 

(1) electrocardiography laboratory and 
testing services^ including stress testing 
and continuous cardiogram monitoring; 

(2) echocardiography service; 

(3) blood gas laboratory; 

(4) nuclear medicine laboratory; 

(5) pulmonary function unit; 

(6) staffed blood bank; 

(7) hematology laboratory or coagulation 
laboratory; 

(8) microbiology laboratory; 

(9) clinical pathology laboratory with facili- 
ties for blood chemistry; 

(10) dedicated cardiac surgical intensive care 
unit that shall be a distinct intensive 
care unit and shall meet the require- 
ments of 10 NCAC 3R .1200 ; 

(11) emergency room with full-time director, 
staffed for cardiac emergencies with 
acute coronary suspect surveillance area 
and voice communication linkage to the 
ambulance service and the coronary 
care unit; and 

(12) cardiac catheterization services includ- 
ing both diagnostic and interventional 
cardiac catheterization capabilities. 

(b) To b e approved th e Stat e Ag e ncy — mu s t 
det e rmin e The applicant shall demonstrate that the 
following services 'mU shall be available to the 
proponent applicant : 

(1) a preventive maintenance program for 
all biomedical devices, electrical instal- 
lations and environmental controls; 

(2) a cardiac rehabilitation program; and 

(3) a community outreach and education 



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1035 



PROPOSED RULES 



program. 

Statutory Authority G.S. 131E-177(1). 

.1718 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) To b e approv e d the State Agenoy must 
d e t e rmin e The applicant shall demonstrate that the 
propon e nt it can meet the following staffing 
requirements: 

(1) one cardiovascular surgeon who has 
been designated to serve as director of 
the open heart surgical surgery program 
and who has the following special 
orodontials qualifications : 

(A) c e rtifi e d certification by the American 
Board of Thoracic Surgery; and 

(B) special qualification in cardiac surg e ry 
thorough understanding of and 
experience in basic medical and 
surgical knowledge and techniques of 
cardiac surgery, cardiopulmonary 
bypass and methods of myocardial 
management ; 

(2) at least one specialized open heart 
surgical team to perform op e n heart 
surgical — proc e dur es composed of at 
least the following professional and 
technical personnel: 

(A) one cardiovascular surgeon board 
certified (or board e ligibl e ) by the 
American Board of Thoracic Surgery; 

(B) one assistant surgeon, preferably a 
cardiovascular or thoracic surgeon; 

(C) one board certified (or board e ligible) 
anesthesiologist trained in open heart 
surgical procedures; 

(D) one certified registered nurse 
anesthetist; 

(E) one circulating nurse or scrub nurse, 
with recent specialized training in 
open heart surgical procedures; 

(F) one operating room technician or 
nurse with recent specialized training 
in open heart surgical procedures; 

(G) twe one certified pump t e chnicians 
technician per operational heart lung 
bypass machine and an additional 
certified pump technician on standby ; 

(H) stafl" for the dedicated cardiac surg e ry 
surgical intensive care unit suffici e nt 
to ensure the availability of 1 RN for 
every 2 patients during the first 48 
hours of post-operative care; 

(3) at least two fully-qualified cardiac 



surgeons on the staff, at least one of 
whom is board-certified , and the other 
at l e ast board e ligible ; one of these 
surgeons mu s t shall be on-call at all 
times; if pediatric open heart surgical 
procedures are performed, one of these 
surgeons must shall be specially trained 
and clinically competent to perform 
pediatric open heart surgical 
procedures, 
(b) To b e approv e d, th e Stat e Agonoy must 
d e t e rmin e TTie applicant shall demonstrate that the 
proponent it can provide the following staff train- 
ing for members of open heart surgical terms: 

(1) certification in cardiopulmonary resus- 
citation and advanced cardiac life sup- 
port; 

(2) an organized program of staff education 
and training which is integral to the 
open heart surgical surgery program 
and which ensures improvements in 
technique and the proper training of 
new personnel. 

Statutory Authority G.S 131E-177(1). 

.1719 DATA REPORTING REQUIREMENTS 

The facility must shall provide^ upon the request 
of the Division of Facility Services, the following 
types of data and information to th e Division of 
Facility S e rvices , in accordance with data format 
and reporting requirements formulated by the 
Division of Facility Services: 

(1) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S 131E-177(1). 

.1720 ACCESSIBILITY 

(a) The applicant shall provide documentation 
describing the mechanism that shall be used to 
insure that the projected number of medically 
underserved shall be served in the facility. 

(b) The applicant shall provide written admis- 
sions policies identifying any prepayment or 
deposit requirements for the facility and stating the 
admission requirements for patients in each of the 
following payor categories: 

(1) Medicare; 
Medicaid; 
Blue Cross and Blue Shield; 



ill 
il) 

14) 
ill 
16) 



Commercial Insurance; 



State Employees Health Plan; 
Self-Pay (includes self-pay, indigent 



1036 



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September 15, 1993 



PROPOSED RULES 



and charity care); and 
(7) Other as identified by the a pplicant. 

(c) The applicant shall provide a written 
description of the billing procedures, including the 
credit and collection policies that shall be utilized 
by the facility. 

(d) The applicant shall document that the health 
care community in the service area, including the 
Departments of Social Services and Health, have 
been invited to comment on the proposed project, 
particularly with regard to the facility's referral 
mechanisms and admissions policies for the 
medically underserved . 

Statutory Authority G.S. 131E-177(1). 

SECTION .1900 - CRITERIA AND 

STANDARDS FOR RADIATION THERAPY 

EQUIPMENT 

.1902 DEFINITION 

Tho following d e finition will apply to all rul e s in 
thio S e ction: 

"Radiation — oncology — a e rvic e s" — means — these 
servic e s provid e d by h e alth care facilities to tr e at 
malignant disease through — th e us e of ionizing 
radiation with e nergy in e xc e ss of IMoV (million 
olootron volta). — This includes th e us e of cobalt 
machin e s, lin e ar aooolerators (with and without 
el e ctron bean capacity), and betatrons. 

Statutory Authority G.S. 131E'177(1). 

.1904 CAPACITY IN THE FACILITY AND 
IN THE HEALTH SERVICE AREA 

^a) A proposal — involving — new or expand e d 

radiation oncology services must be consistent with 
the applicabl e North Carolina Stat e Health Plan 
(th e one in eflF e ot at time of the final agency 
d e ci s ion) and with th e applicable health systems 

(b) A proposal — involving — n e w or expand e d 

radiation oncology services must sp e cify: 

{\) th e current capabiliti es and capaciti e s of 

the — proponent' s — aggregate — radiation 
oncology services. 

^3) the capabilities and capacities of th e 

proponent' s aggr e gate radiation 

oncology servic e s following the 

completion of th e propos e d project. 

(e) A proposal — involving new or expand e d 

radiation oncology oervic e s shall not bo approv e d 
unless existing services of the type b e ing propos e d 
are demonstrated to be currently utiliz e d at 80 
p e rc e nt — ef — annual — capacity. — Fef — purposes — ef 



capacity det e rmination s . minimal se rvic e 

availability shall be consider e d to be eight hours 
p e r day, fiv e days p e r w ee k. — In no cas e shall a 

proposal involving an additional cobalt, 

m e gavoltag e , — or sup e rvoltag e unit bo approved 
unl e ss each e xisting cobalt, m e gavoltage. or sup e r 
voltag e — ttftit — curr e ntly — p e rforms — at — teast — 6000 
treatments p e r year with tho exception that units 
performing l e ss than 6000 treatm e nts p e r y e ar shall 
b e acc e ptabl e if: 

{\) tho units ar e d e dicat e d primarily for 

special purposes, e.g., el e ctron bean, 

research, t e aching; 
{3) th e units, having attained their useful 

iife; — are — retain e d — and — operat e d — fef 

em e rg e ncy backup; or 
03 the e xisting unit is not m e eting a need 

which e xists in th e health s e rvic e ar e a. 

Statutory Authority G.S. 131E-177(1). 

.1905 SCOPE OF SERVICES OFFERED 

A proposal to provid e n e w or expand e d radiation 
oncology servic e s must docum e nt the ext e nt to 
which the following will be available. — If any item 
will not be available, then substantive information 
must be given obviating the n ee d for that it e m 
b e for e approval for a n e w or e xpand e d s e rvic e con 
b e giv e n: 

f!^ distinct. identifiable — area — fef — the 

provision of the propos e d servic e ; 

{3) a — program — ef — radiation — oncology 

continuing — e ducation — fef — t e chnologists 
and m e dical s tafl^; 
(3) — a program dev e lop e d and implement e d 
fef — the — collection — ef — utilization — data 
relativ e to th e propon e nt's provision of 
radiation oncology services. 

Statutory Authority G.S 131E-177(1). 

.1906 PROJECTED UTILIZATION 

(a) — A proposal to provid e n e w or e xpand e d 
radiation oncology s ervic es mu s t proj e ct pati e nt 
utilization for each of the fir s t e ight calendar 
quart e r s following the completion of the proposed 
proj e ct. — All assumptions, including the specific 
methodology by which — utilization — i s proj e cted, 
mu s t b e clearly s tat e d. 

fb) — A proposal to provide new or expanded 
radiation oncology se rvice s s hall not b e approv e d 
unl e ss all s ervic es of the type being propo se d are 
proj e ct e d to b e utiliz e d at 8 p e rcent of the annual 
capacity within thr e e years of initiation. — In no 
case shall a proposal involving new or additional 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1037 



PROPOSED RULES 



suporvoltage. — cobalt. — er — mogavoltag e — lin e ar 
acc e l e rator uniu be approved unless utilization of 
the e quipment is proj e cted to bo at least 6000 
procedur e s — per year — ne — lat e r than thr ee years 
following the activation of usag e of th e e quipment. 

Statutory Authority G.S. 131E-177(1). 

.1907 SITE 

A proposal to provid e n e w or e xpand e d radiation 
oncology s e p i 'iocs must provide docum e ntation to 
show that the servic e s will be off e r e d in a physical 
e nvironment that conforms to th e r e quir e m e nts of 
f e d e ral, stat e , and local r e gulatory bodi es . 

Statutory Authority G.S 131E-177(1). 

.1908 STAFFING 

A proposal to provid e now or expand e d radiation 
oncology s e rvic e s must provid e docum e ntation to 
show that th e appropriat e typ e s and numb e rs of 
staff. — particularly — qualifi e d — technologists — afid 
m e dical — staff. — w+y — b e availabl e to support th e 
servic e s. — A propon e nt must hav e availabl e , or 
committ e d to be availabl e a physician lic e ns e d to 
practic e — m e dicin e — m — North — Carolina. — wbe — 1« 
qualifi e d and authoriz e d by th e propon e nt's faoilir\i' 
te — perform — radiation oncology — proc e dures. — te 
s upervis e all radiation oncology proc e dur e s. 

Statutory Authority G.S. 131 E- 177(1). 

.1912 DEFINITIONS 

These definitions shall apply to all rules in this 
Section: 

(1 ) "Approved linear accelerator" means a 
linear accelerator which uas not 
operational prior to the beginning of the 
rev lev.' period but which had been issued 
a certificate of need or had been acquired 
prior to .March 18. 1993 in accordance 
with G.S. 131E-175. et. al. 

(2) "Existing linear accelerator" means a 
linear accelerator in operation prior to the 
beginning of the re\'iew period. 

(3) "Linear accelerator" means MRT 
equipment which is used to deliver a 
beam of electrons or photons in the 
treatment of cancer patients. 

(4) "Linear accelerator service area" means 
a geographical area, defined by the 
applicant, in which a linear accelerator 
provides services and in v.'hich no less 
than 120.000 persons reside. 

(5) "Mega\'oltage unit" means MRT 



i6j 



m 



£8] 
i9i 



(10) 



equipment which provides a form of 
teletherapy that involves the delivery of 
energy greater than, or equivalent to. one 
million volts by the emission of x-rays, 
gamma rays. electrons. or other 
radiation. 

"Megavoltage radiation therapy (MKT)" 
means the use of ionizing radiation m 
excess of one million electron volts in the 
treatment of cancer. 

"MRT equipment" means a machine or 
energy source used to provide 
mega\'oltage radiation therapy including 
linear accelerators and other particle 
accelerators. 

"Radiation therapy equipment" means 
medical equipment which is used to 
provide radiation therapy services. 
"Radiation therapy services" means those 
services v.'hich invohe the deliver\' of 
precisely controlled and monitored doses 
of radiation to a well defined \'olume of 
tumor bearing tissue v.'ithin a patient- 
Radiation may be delivered to the tumor 



region by the use of radioacti\e implants 
or by beams of ionizing radiation or it 
may be delivered to the tumor region 
systemically. 

"Radiation therapy service area" means 
the geographic area in which radiation 
therapy services are proposed to be 
provided by the applicant. 
"Simulator" means a machine that 
produces high quality diagnostic 
radiographs and that is capable of 
precisely reproducing the geometric 
relationships of the MRT equipment to 
the patient. 



Statutory Authority G.S. 131E-177(1). 

.1913 INTORMATION REQLTRED OF 
APPLICANT 

(a) An applicant proposing to acquire radiation 
therapy equipment shall use the Acute Care 
Facilirv'/Medical Equipment application form. 

(b) An applicant proposing to acquire radiation 
therapy equipment shall also provide the following 
additional information: 

( 1 ) a description of the boundaries of the 
proposed radiation therapy ser\'ice area 
or the pro posed linear accelerator 
service area if the applicant proposes to 
acquire a linear accelerator: 

(2) a list of the existing radiation therapy 



1038 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



(3) a list of 



equipment in the proposed radiation 
therapy service area or linear 
accelerator service area; 
a list of all the radiation therapy 
equipment to be acquired and 
documentation of the capabilities and 
capacities of each item of equipment; 

(4) documentation of the purchase price 
and fair market value of each piece of 
radiation therapy equipment, each 
simulator, and any other related 
equipment proposed to be acquired; 

(5) the projected number of patient 
treatments to be performed on each 
piece of radiation therapy equipment for 
each of the first eight calendar quarters 
following the completion of the 
proposed project and documentation of 
all assumptions by which utilization is 
projected; 

(6) documentation that the proposed 
radiation therapy equipment shall be 
operational at least seven hours per 
day, five days a week; 

(7") documentation that no more than one 
simulator is available for every two 
linear accelerators in the applicant's 
facility, except that an applicant that 
has only one linear accelerator may 
have one simulator; and 

(8) documentation that the services shall be 
offered in a physical environment that 
conforms to the requirements of 
federal, state, and local regulatory 
bodies. 

Statutory Authority G.S. 131E-177(1). 

.1914 REQUIRED PERFORMANCE 
STANDARDS 

(a) An applicant proposing to acquire a linear 
accelerator shall demonstrate that each of the 
following standards shall be met: 

(1) each existing linear accelerator in the 
proposed service area served at least 
250 patients or provided 6.400 
treatments in the twelve months prior to 
the date the application was submitted, 
with the exception that existing linear 
accelerators that performed less than 
6.400 treatments per year shall not be 
held to this standard if the applicant can 
provide documentation that: 
(A) the patient characteristics or tumor 
types treated by the existing linear 



accelerator are complex and require 
more treatment time per patient; and 
£B} the existing linear accelerator is 
committed to clinical research and 
teaching; 

(2) each proposed new linear accelerator 
shall be utilized at an annual rate of 
250 patients or 6.400 treatments during 
the third year of operation of the new 
equipment; and 

(3) each existing and a pproved linear 
accelerator shall be projected to be 
utilized at an annual rate of 250 patients 
or 6.400 treatments during the third 
year of operation of the new equipment. 

fb) An applicant proposing to acquire radiation 
therapy equipment other than a linear accelerator 
shall provide the following information: 

(1) the number of patients that are 
projected to receive treatment from the 
proposed radiation therapy equipment, 
classified by type of equipment, 
diagnosis, treatment procedure, and 
county of residence; and 

(2) the maximum number and type of 
procedures that the proposed equipment 
is capable of performing. 

(c) The applicant shall document all assumptions 
and provide data supporting the methodology used 
to determine projected utilization as required in 
this Rule. 

Statutory Authority G.S. 131E-177(1). 

.1915 REQUIRED SUPPORT SERVICES 

An applicant proposing to acquire radiation 

therapy equipment shall document that the 

following items shall be available; and if any item 

shall not be available, the applicant shall provide 

substantive information obviating the need for that 

item: 

(1) a program of radiation therapy continuing 

education for technologists and medical 

staff; 



01 



14} 
15} 



a program for the collection of utilization 
data relative to the applicant's provision 
of radiation therapy services; 
medical laboratory services; 
pathology services; and 
pharmaceutical support services. 



Statutory Authority G.S. 131E-177(1). 

.1916 REQUIRED STAFFING AND STAFF 
TRAINING 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1039 



PROPOSED RULES 



(a) An applicant proposing to acquire radiation 
therapy equipment shall document that: 

(1) the appropriate types and numbers of 
staff, particularly qualified radiation 
therapists and medical staff, shall be 
available to support the proposed 
services; and 

(2) a board-certified Radiation-Oncologist 
licensed to practice medicine ]n North 
Carolina shall be available to perform 
radiation therapy procedures and 
supervise all radiation therapy 
procedures. 

(h) An applicant proposing to acquire radiation 
therapy equipment shall provide documentation to 
demonstrate the availability of the following stafF: 
(1) Radiation-Oncologist; 

Radiation Physicist; 

Dosimetrist or Physics Assistant; 

Physics Technologist; 

Radiation Therapist; 

Radiation-Oncology Administrator; 

Registered Nurse or LPN; 

Physical Therapist; 

Dietician; 

Pharmacist; 



12} 

(31 

14] 

15} 

(6} 

ill 

£8] 

(9] 

(10) 

01} 

(12) 



Social Worker; and 
Maintenance Engineer. 



Statutory Authority G.S. I31E-177(1). 

.1917 ACCESSIBILIT\ 

(a) The applicant shall document the mechanism 
that will be used to insure that the projected 
number of medically underserved will be served by 
the applicant. 

£b] The applicant shall provide written 
admissions policies identifying any prepayment or 
deposit requirements for the proposed services and 
stating the admission requirements for patients in 
each of the following payor categories: 
(1) Medicare; 
£2) Medicaid; 

(3) Blue Cross and Blue Shield; 

(4) Commercial Insurance; 

(5) State Employees Health Plan; 

(6) Self-Pay (includes self-pay, indigent 
and charity care); and 

(7) Other as identified by the applicant. 

(c) The applicant shall provide a written 
description of the billing procedures, including the 
credit and collection policies that will be utilized 
by the applicant. 

(d) The applicant shall document that the health 
care community in the service area, including the 



Departments of Social Services and Health, have 
been invited to comment on the proposed project, 
particularly with regard to the applicant's referral 
mechanisms and admissions policies for the 
medically underserved. 

Statutory Authority G.S. 13]E-177(1). 

.1918 DATA REPORTING REQUIREMENTS 

The applicant shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information, in 
accordance with data format and reporting 
requirements formulated by the Division of 
Facility Services: 

(1) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S. 131E-177(1). 

SECTION .2100 - CRITERIA AND 

STANDARDS FOR AMBULATORY 

SURGICAL SERVICES 

.2113 DEFINITIONS 

The following definitions -wiH shall apply to all 
rules in this Section: 

(1) "Ambulatory surgical case" means an 
individual who receives one or more 
ambulatory surgical procedures in an 
ambulatory surgical operating room 
during a single operative encounter. 

(2) "Ambulatory surgical service area" 
means a single or multi-county area as 
used in the development of JO NCAC 3R 
.3030. 

(3) 43) "Ambulatory surgical services" means 
those surgical services provided to 
patients as part of an ambulatory surgical 
program within a licensed ambulatory 
surgical facility or a general acute care 
hospital licensed under G.S. Chapter 
131E, Article 5, Part A. 

(4) 0} "Ambulatory surgical facility" means 
a facility as defined in G.S. 131E- 176(4^ 
(la) . 

(5) (6) "Ambulatory surgical operating 
room" means a dedicated or shared 
operating room in a licensed ambulatory 
surgical facility, or a general acute care 
hospital licensed under G.S. 131E, 
Article 5, Part A, that is fully equipped 
to perform surgical procedures and is 
constructed to meet the specifications and 



1040 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



standards, including fire and life safety 
code requirements, appropriate to the 
type of facility as utilized by the 
Construction Section of the Division of 
Facility Services. Ambulatory surgical 
operating rooms exclude operating rooms 
dedicated for the performance of inpatient 
surgical procedures, cast rooms, 
procedures rooms that do not meet 
operating room specifications, suture 
rooms, YAG laser rooms, and cystoscopy 
and endoscopy procedure rooms that do 
not meet the specifications of an 
operating room. 

(6) (4) "Ambulatory surgical program" 
means a program as defined in G.S. 
131E-176f+a)£lbj. 

(7) (5) "Ambulatory surgical procedure" 
means a surgical procedure performed in 
a surgical operating room which requires 
local, regional or general anesthesia and 
a period of post-operative observation of 
less than 24 hours. Ambulatory surgical 
procedures exclude those procedures 
which are generally performed more than 
50 percent of the time in a physician's 
office. 

(8) f?) "Existing ambulatory surgical 
operating rooms" means only th e those 
ambulatory surgical operating rooms in 
ambulatory surgical facilities and 
hospitals which were reported eft in the 
License Application for Ambulatory 
Surgical Facilities and Programs and in 
Part III of Hospital Licensure Renewal 
Application Form submitted to the 
Licensure Section of the Division of 
Facility Services and which were licensed 
and certified prior to the beginning of the 
review period. 

(9) 48) "Approved ambulatory surgical 
operating rooms" means only th e those 
ambulatory surgical operating rooms that 
havo bcx>n were approved for a certificate 
of need by the Certificate of Need 
Section prior to the date on which the 
applicant's proposed project was 
submitted to the Agency but that have not 
been licensed and certified^:; — and 
ambulatory surgical The term also means 
those operating rooms which the 
Certificate of Need Section determined 
were not subject to certificate of need 
review and are which were under 
construction prior to the date the 



applicant's proposal was submitted to the 
Agency. 

(10) (9) "Dedicated ambulatory surgical 
operating room" means an ambulatory 
surgical operating room used solely for 
the performance of ambulatory surgical 
procedures. 

(11) "Multispecialty ambulatory surgical 
program" means a program as defined in 
G.S. 131E-176(15a). 

(12) (4^ "Shared surgical operating room" 
means an ambulatory surgical operating 
room that is used for the performance of 
both ambulatory and inpatient surgical 
procedures. 

(13) fl4) "Specialty area" means an area of 
medical practice in which there is an 
approved medical specialty certificate 
issued by a member board of the 
American Board of Medical Specialties 
and includes, but is not limited to the 
following: gynecology, otolaryngology, 
plastic surgery, general surgery, 
ophthalmology, urology, orthopedics, and 
oral surgery. 

(14) "Specialty ambulatory surgical program" 
means a program as defined in G.S. 
131E-176(24c). 

(15) {45) "Practical utilization" is 4.3 surgical 
cases per day for a dedicated ambulatory 
surgical operating room and 3.5 surgical 
cases per day for a shared surgical 
operating room. 

^43) "Service area" moans a singl e or multi 

county ar e a as designat e d in 10 NCAC 
3R .3020. 

Statutory Authority G.S. 131E-177(1). 

.2114 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing to establish a new 
ambulatory surgical facility, to increase the 
number of ambulatory surgical operating rooms in 
an existing ambulatory surgical facility or hospital, 
to convert a specialty ambulatory surgical program 
to a multispecialty ambulatory surgical program or 
to add a specialty to a specialty ambulatory 
surgical program shall identify each of the 
following specialty areas that will be provided in 
the facility: 

(1) gynecology; 

(2) otolaryngology; 

(3) plastic surgery; 

(4) general surgery; 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1041 



PROPOSED RULES 



i51 
£61 

m 

£81 



ophthalmology; 

orthopedic; 

oral surgery; and 

other specialty area identified by the 

applicant. 
(h) An applicant proposing to establish a new 
ambulatory surgical facility^ ef to increase the 
number of ambulatory surgical operating rooms in 
an existing ambulatory surgical facility or hospital, 
to convert a specialty ambulatory surgical program 
to a multispecialty ambulatory surgical program or 
to add a specialty to a specialty ambulatory 
surgical program shall provide the following 
information regarding the services to be offered in 
the facility following completion of the project: 
(1) the number and type of existing and 

proposed dedicated ambulator^' surgical 

operating roomsT ; 

the number and type of existing and 

proposed shared ambulatory surgical 

operating rooms^j 

the number and type of shared 



(2) 



m 



£41 



£51 

£61 
£21 



£81 



ambulaton,' surgical operating rooms 

that are proposed to be converted to 

dedicated ambulatory surgical operating 

rooms; 

{^ the current and projected number of 

surgical procedures, identified by CFT 

code or ICD-9-CM procedure code, to 

be performed in the ambulatory surgical 

operating rooms-^i 

f4) the fixed and movable equipment to 

be located in each ambulatory surgical 

operating roomTi 

4^ the hours of operation of the 

ambulatory surgical program^ i 

if the applicant is an existing 

ambulatory surgical facility, the average 

charge for the 20 surgical procedures 

most commonly performed in the 

facility during the preceding tv.'elve 

months and a list of all serN'ices and 

items included in each charge; 



the projected average charge for the 20 
surgical procedures which the applicant 
projects will be performed most often 
iii the proposed ambulatory' surgical 
program and a list of all services and 
items in each charge; 

{4) the projected averag e charg e for the 20 

most — common — s urgical — proc e dures 
curr e ntly p e rform e d and propos e d to b e 
p e rform e d in th e ambulator^' surgical 
program and a list of all services and 
it e ms includ e d in e ach charg e . 



(9) f?) identification of providers of pre- 
operative services and procedures 
which will not be included in the 
facility's charge^ j and 

(10) f8) other information as required in the 
application. 

Statutory Authority G.S. 131E-177(1). 

.2115 REQUIRED PERFORMANCE 
STANDARDS 

(a) In projecting utilization for existing, 
approved, afld proposed and expanded ambulatory 
surgical programs, a program shall be considered 
to be open five days per week and 52 weeks a 
year. 

fb) A proposal to establish a new ambulatory 
surgical facility^ ef to increase the number of 
ambulatory surgical operating rooms in an existing 
ambulatory surgical facility or hospital^ to convert 
a specialty ambulatory surgical program to a 
multispecialty ambulatory' surgical program or to 
add a specialty' to a s pecialty ambulatory surgical 
program shall not be approved unless the applicant 
documents that the average number of ambulatory 
surgical cases per each ambulator^' surgical 
operating room in the applicant's proposed 
ambulatory surgical program are projected to be at 
practical utilization operatin g at 4J surgical cases 
per day for each dedicated ambulatory surgical 
operating room and 3.5 surgical cases per day for 
each shared surgical operating room during the 
fourth quarter of the third year of operation 
following completion of the project. 

(c) An applicant proposing to convert a specialty 
ambulators' surgical program to a multispecialty 
ambulatory surgical program or to add a specialty 
to a specialty ambulatory surgical program shall 
provide documentation to show that each existing 
ambulatory surgepy' program in the ambulatory' 
surgical sers'ice area that performs ambulatory 
surgery in the same specialty areas as proposed in 
the application is currently operating at 4.3 
surgical cases per day for each dedicated 
ambulatory surgical operating room and 3.5 
surgical cases per day for each shared surgical 
operating room. 

(d) An applicant proposing to convert a specialty 
ambulatory surgical program to a multispecialty 
ambulatory surgical program or to add a specialty 
to a specialty ambulaton,' surgical program shall 
provide documentation to show that each existing 
and approved ambulatory' surgery program jn the 
ambulatory surgical service area that performs 
ambulatory surgery in the same specialty areas as 



1042 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



proposed in the application is projected to be 
operating at 43 surgical cases per day for each 
dedicated ambulatory surgical operating room and 
3.5 surgical cases per day for each shared surgical 
operating room prior to the completion of the 
proposed project. The applicant shall document 
the assumptions and provide data supporting the 
methodology used for the projections. 

Statutory Authority G.S. 131 E- 177(1). 

.2116 FACILITY 

(a) An applicant proposing to establish a 
licensed ambulatory surgical fecility that will be 
physically located in a physician's or dentist's 
office or within a general acute care hospital shall 
demonstrate that reporting and accounting 
mechanisms exist and can be used to confirm that 
the licensed ambulatory surgery facility is a 
separately identifiable entity physically^ and 
administratively, and is financially independent and 
distinct from other operations of the facility in 
which it is located. 

(b) An applicant proposing a licensed 
ambulatory surgical facility shall receive 
accreditation from the Joint Commission for the 
Accreditation of Healthcare Organizations, the 
Accreditation Association for Ambulatory Health 
Care or a comparable accreditation authority 
within two years of completion of the facility. 

(c) An applicant proposing to establish a new 
ambulatory surgical facility^ er to increase the 
number of ambulatory surgical operating rooms in 
an existing ambulatory surgical facility or hospital^ 
to convert a specialty ambulatory surgical program 
to a multispecialty ambulatory surgical program or 
to add a specialty to a specialty ambulatory 
surgical program shall document that the physical 
environment of the facility conforms to the 
requirements of federal, state, and local regulatory 
bodies. 

(d) In competitive reviews, an applicant 
proposing to perform ambulatory surgical 
procedures in at least three specialty areas will be 
considered more favorably than an applicant 
proposing to perform ambulatory surgical 
procedures in fewer than three specialty areas. 

(e) TTie applicant shall provide a floor plan of 
the proposed facility clearly identifying the 
following areas: 

(1) receiving/registering area^i 

(2) waiting area^i 

(3) pre-operative area^i 

(4) operating room by type-f^ 

(5) recovery area^; and 



(6) observation area. 
(f) An applicant proposing to expand by 
converting a specialty ambulatory surgical program 
to a multispecialty ambulatory surgical program or 
by adding a specialty to a specialty ambulatory 
surgical program that does not propose to add 
physical space to the existing ambulatory surgical 
facility shall demonstrate the capability of the 
existing ambulatory surgical program to provide 
the following for each additional specialty area: 

(1) physicians; 

(2) ancillary services: 

(3) support services; 

(4) medical equipment; 

(5) surgical equipment; 

(6) receiving/ registering area; 

(7) clinical support areas; 

(8) medical records; 

(9) waiting area; 

(10) pre-operative area; 

(1 1) operating rooms by type; 

(12) recovery area; and 

(13) observation area. 

Statutory Authority G.S 1 31 E- 177(1). 

.2117 ACCESSIBILITY 

(a) An applicant proposing to establish a new 
ambulatory surgical facility^ ©f to increase the 
number of ambulatory surgical operating rooms in 
an existing ambulatory fecility or hospital^ to 
convert a specialty ambulatory surgical program to 
a multispecialty ambulatory surgical program or to 
add a specialty to a specialty ambulatory surgical 
program shall provide assurance that the facility, 
unless solely designated as a birthing center, will 
be certified for Medicaid and Medicare 
reimbursement upon completion of the project. 

(b) The applicant shall provide documentation 
describing the mechanism that will be used to 
insure that the projected number of medically 
underserved will be served in the facility. 

(c) The applicant shall provide a copy of the 
written admissions policies identifying any 
prepayment or deposit requirements for the facility 
and clearly stating the admission requirements for 
the following payor categories: 

(1) privat e pay. Medicare; 

m e dicaid bcncficiarios. Medicaid; 
medicare b e nefioiarieo. Blue Cross and 
Blue Shield; 

indigent 



(2) 
(3) 



(4) 
(5) 



uninsured 



patients. 



Commercial Insurance; 

und e rinsur e d — indig e nt — pati e nts, — and 

State Employees Health Plan; 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1043 



PROPOSED RULES 



(6) fully insur e d pati e nts. Self-Pay 

(includes self-pay, indigent and charity 
care); and 

(7) Other as identified by the applicant. 

(d) The applicant shall provide a written 
description of the billing procedures, including the 
credit collection policies, that will be utilized by 
the fecility. 

(e) The applicant shall document that the health 
care community in the ambulatory surgical service 
area, including the Departments of Social Services 
and Health, have been invited to comment on the 
proposed project, particularly with regard to the 
facility's referral mechanisms and admissions 
policies for the medically underserved. 

(f) The applicant shall provide documentation 
that the facility will match or exceed the average 
percent of patients in the combined categories of 
Medicare, Medicaid, charity care and bad debt 
provided by the existing and approved ambulatory 
surgical programs in the propos e d ambulatory 
surgical service area in which the applicant's 
facility is, or will be, located . 

Statutory Authority G.S. 131E-177(1). 

.2118 REQUIRED STAFFESfG AND STAFF 
TRAINING 

(a) An applicant proposing to establish a new 
ambulatory surgical facilityj^ ef to increase the 
number of ambulatory surgical operating rooms in 
an existing ambulatory surgical facility or hospitaK 
to convert a specialty ambulatory surgical program 
to a multispecialty ambulators' surgical program or 
to add a specialty to a specialty ambulatory 
surgical program shall identify^ afid justify and 
document the availability of the number of current 
and proposed staff to be utilized in the following 
areas: 

(1) administration-; i 

(2) pre-operativcT ^ 

(3) post-operativcr i 

(4) operating roomT : and 

(5) other. 

(b) The applicant shall e stimat e identify' the 
number of physicians who currently utilize the 
facility and estimate the number of physicians 
expected to utilize the facility and the criteria to be 
used by the facility in extending surgical and 
anesthesia privileges to medical personnel. 

(c) The applicant shall provide documentation 
that physicians with privileges to practice in the 
facility will be active members in good standing at 
a general acute care hospital within the propos e d 
ambulatory surgical service area in which the 



facility is, or will be, located or will have written 
referral procedures with a physician who is an 
active member in good standing at a general acute 
care hospital in the propo se d ambulatory surgical 
service area. 

Statutory Authority G.S 131 £-177(1). 

.2119 REQUIRED SUPPORT SERVICES 

(a) An applicant proposing to establish a new 
ambulatory surgical facility^ er increase the num- 
ber of ambulatory surgical operating rooms in an 
existing ambulatory surgical facility or hospital^ 
convert a specialty ambulatory surgical program to 
a multispecialty ambulatory surgical program or 
add a specialty to a specialty ambulatory surgical 
program shall provide written policies and proce- 
dures demonstrating that the facility will have 
patient referral, transfer, and followup procedures. 

(b) The applicant shall provide documentation 
showing the proximity of the proposed facility to 
the following services: 

(1) emergency services^ ; 

(2) support servicesT i 

(3) ancillary services; i and 

(4) public transportation. 

Statutory Authority G.S. 131 £-177(1). 

.2120 DATA REPORTING REQUIREMENTS 

The facility shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information, in accor- 
dance with data format and reporting requirements 
formulated by the Division of Facility Services: 

(1) demographic data on patients treated: 

(2) financial data: and 

(3) clinical data. 

Statutory Authority G.S 131 £-177(1). 

SECTION .2300 - CRITERIA AND STAN- 
DARDS FOR COMPUTED TOMOGRAPHY 
EQUTPMEIVT 

.2314 DEFEVITIONS 

The following definitions shall apply to all rules 
in this Section: 

(1) "A pproved computed tomography (CT) 
scanner" means a CT scanner which was 
not operational prior to the beginning of 
the review period but which had been 
issued a certificate of need or had been 
acquired prior to March 18, 1993 in 
accordance with G.S. 131E-175, et. al. 



1044 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



(2) "Computed tomography" means a 
technique whereby a sharply coUimated 
X-ray beam is passed through the human 
body from a source which rotates around 
the body in a specific arc. As the beam 
passes through the body from its 
perimeter, its intensity is reduced. The 
transmitted intensity of the beam varies 
in accordance with the density of the 
tissue it passes through and is measured 
by sensitive detectors and, from this 
information, two-dimensional cross- 
sectional pictures or other images may be 
generated. A computer is used to 
generate the image from the 
measurements of X-ray beam intensity- 
Tissue images can be done with or 
without contrast agents. Computed 
tomography services are rendered by CT 
scanners. 

(3) "Computed tomography (CT) scanner" 
means an imaging machine which 
combines the information generated by a 
scanning X-ray source and detector 
system with a computer to reconstruct an 
cross-sectional image of the full body, 
including the head. 

(4) "Computed tomography (CF) service 
area" means a geographical area defined 
by the applicant, which has boundaries 
that are not farther than 40 road miles 
from the facility. 

(5) "CT scan" means one discrete image of a 
patient produced by a CT scanner. 

(6) "Existing CT scanner" means a computed 
tomography scanner in operation prior to 
the beginning of the review period. 

(7) "Fixed CT scanner" means a CT Scanner 
that is used at only one location or cam- 
pus. 

(8) "HECT unit" means a unit that is equiva- 
lent to one CT scan which is derived by 
applying a weighted conversion factor to 
a CT scan in accordance with the Head 
Equivalent Computed Tomography stud- 
ies formula developed by the National 
Electric Manufacturers, based on the 
"Leonard Methodology". 

(9) "Mobile CT scanner" means a CT scan- 
ner and transporting equipment which is 
moved to provide services at two or more 
host facilities. 

Statutory Authority G.S. 131E-177(1). 



8:12 NORTH CAROLINA REGISTER September 15, 1993 1045 



PROPOSED RULES 



.2315 INFORMATION REQUIRED OF APPLICANT 

(a) An a pplicant proposing to acquire a CT scanner shall use the acute care facility/medical equipment 
application form. 

(b) An applicant proposing to acquire a CT scanner shall provide the number of CT scans that have been 
performed on its existing CT scanners for each type of CT scan listed below for the previous 12 month 
period: 

head scan without contrast; 



ill 
12} 

01 
14} 
(5} 
(61 



head scan with contrast; 



head scan without and with contrast; 

body scan without contrast; 

body scan with contrast; and 

body scan without contrast and with contrast. 

(c) TTie applicant shall project the number of CT scans to be performed on the new CT scanner for each 
type of CT scan listed below for the first 12 quarters the new CT scanner is proposed to be operated: 

(1) head scan without contrast; 

(2) head scan with contrast; 

(3) head scan without and with contrast; 

(4) body scan without contrast; 

(5) body scan with contrast; and 

(6) body scan without contrast and with contrast. 

(d) The applicant shall convert the historical and projected number of CT scans to HECT units as follows: 





Type of CT Scan 


No. of 
Scans 




Conver. 
Factor 




HECT 

Units 


i 


Head without contrast 




X 


1.00 


^ 




2 


Head with contrast 




X 


1.25 


^ 




3 


Head without and with contrast 




X 


1.75 


= 




4 


Body without contrast 




X 


1.50 


= 




5 


Body with contrast 




X 


1.75 


^ 




6 


Body without contrast and with 
contrast 




X 


2.75 


— 





(e) An a pplicant proposing to acquire a mobile CT scanner shall provide the information requested in 
Paragraphs (b), (c), and (d) of this Rule for each proposed host facility. 

(f) The applicant shall provide all projected direct and indirect operating costs and all projected revenues 
for the provision of CT services for the first 12 quarters the new CT scanner ]s proposed to be operated. 

(g) The applicant shall provide projected costs and projected charges by CPT code for the first 12 quarters 
the new CT scanner is proposed to be operated. 

(hj If an applicant that has been utilizing a mobile CT scanner proposes to acquire a fixed CT scanner 
for its facility, the applicant shall demonstrate that its projected charge per CPT code shall not increase more 
than 10% over its current charge per CPT code on the mobile CT scanner. 

£i} An a pplicant proposing to acquire a mobile CT scanner shall provide copies of letters of intent from 
and proposed contracts with all of the proposed host facilities of the new CT scanner. 

(j) An applicant proposing to acquire a CT scanner shall demonstrate that it has a written commitment 
from the radiology group of a hospital that it will accept CT readings from the a pplicant. 

(k) An applicant proposing to acquire a CT scanner shall demonstrate that the applicant has the capability 
of performing CT scan procedures 12 hours per day, six days per week. 

Statutory Authority G.S. 131E-177(1). 



1046 



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September 15, 1993 



PROPOSED RULES 



.2316 REQUIRED PERFORMANCE 
STANDARDS 

An applicant proposing to acquire a CT Scanner 
shall demonstrate each of the following: 

(1) each fixed or mobile CT Scanner to be 
acquired shall be projected to perform 
5,100 HECT units annually in the third 
year of operation of the proposed equip- 
ment; 

(2) each existing fixed CT scanner in the 
applicant's CT service area shall have 
performed at least 5,100 HECT units m 
the 12 month period prior to submittal of 
the application; 

(3) each existing and approved fixed CT 
scanner in the applicant's CT service area 
shall be projected to perform 5,100 
HECT units annually in the third year of 
operation of the proposed equipment; 

(4) each existing mobile CT scanner in the 
proposed CT service area performed at 
least an average of 20 HECT units per 
day per site in the CT scanner service 
area in the Vl months prior to submittal 
of the application; and 

(5) each existing and approved mobile CT 
scanner shall perform at least an average 
of 20 HECT units per day per site in the 
CT scanner service area in tlie third year 
of operation of the proposed equipment. 

Statutory Authority G.S. 131E-177(1). 

.2317 REQUIRED SUPPORT SERVICES 

(a) An applicant proposing to acquire a CT 
scanner shall document the availability of the 
following diagnostic services: 

(1) diagnostic radiology services; 

(2) therapeutic radiology services; 

(3) nuclear medicine services; and 

(4) diagnostic ultrasound services. 

(b) An applicant proposing to acquire a CT 
scanner shall document the availability of services 
to treat patients with the following conditions: 

(1) neurological conditions; 

(2) thoracic conditions; 

(3) cardiac conditions; 

(4) abdominal conditions; 

(5) medical oncological conditions; 

(6) radiological oncological conditions; 

(7) gynecological conditions; 

(8) neurosurgical conditions; and 

(9) genitourinary and urogenital conditions. 

(c) An applicant proposing to acquire a mobile 
CT scanner shall provide: 



(1) referral agreements between each host 
site and at least one other provider of 
CT services in the proposed CT service 
area to document the availability of CT 
services if patients require them when 
the mobile unit is not in service at that 
host site; and 

(2) documentation that each of the services 
listed in Paragraphs (a) and (b) of this 
Rule shall be available at each host 
facility. 

Statutory Authority G.S 131 E- 177(1). 

.2318 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) An applicant proposing to acquire a CT 
scanner shall demonstrate that it can meet the 
following staffing requirements: 

(1) one Board certified radiologist who has 
had: 

(A) training in computed tomography as 
an integral part of his or her residen- 
cy training program; or 

(B) six months of supervised CT experi- 
ence; or 

(C) at least three months of fellowship 
training, or its equivalent, in CT; or 

(D) an appropriate combination of CT 
experience and fellowship training 
equivalent to Parts (a)(1) (A), (B), or 
(C) of this Rule; 

(2) at least one radiology technologist 
registered by the American Society of 
Radiologic Technologists shall be pres- 
ent during the hours of operation of the 
CT unit; and 

(3) a radiation physicist with training in 
medical physics shall be available for 
consultation for the calibration and 
maintenance of the equipment. The 
radiation physicist may be an employee 
or an independent contractor. 

(b) An applicant proposing to acquire a CT 
scanner shall demonstrate that the following staff 
training is provided: 

(1) certification in cardiopulmonary resus- 
citation (CPR) and basic cardiac life 
su pport; and 

(2) an organized program of staff " education 
and training which is integral to the 
services program and ensures improve- 
ments in technique and the proper 
training of new personnel. 

(c) An applicant proposing to acquire a mobile 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1047 



PROPOSED RULES 



CT scanner shall document that the requirements 
in Paragraphs (a) and fb) of this Rule shall be met 
at each host facility. 

Statutory Authority G.S. 131E-I77(1). 

.23 1 9 DATA REPORTING REQUIREMENTS 

The applicant shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information to the in 
accordance with data format and reporting require- 
ments formulated by the Division of Facility 
Services: 

( 1 ) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S. 131 £-177(1). 

.2320 ACCESSIBILITY 

(a) The applicant shall provide documentation 
describing the mechanism that will be used to 
insure that the projected number of medically 
underserved will be served in the unit. 

(b) The applicant shall provide written admis- 
sions policies identifying any prepayment or 
deposit requirements for the unit and stating the 
admissions requirements for patients in each of the 
following payor categories: 



lii 
12) 
£3} 
14] 
£5} 
16} 



Medicare; 

Medicaid; 

Blue Cross and Blue Shield; 

Commercial Insurance; 



indigent 



Gl 



State Employees Health Plan; 
Self- Pay (includes self-pay, 
and charity care); and 
Other as identified by the applicant. 

(c) The applicant shall provide a written descrip- 
tion of the billing procedures, including the credit 
collection policies, that will be utilized by the unit. 

(d) The applicant shall document that the health 
care community in the service area, including the 
Departments of Social Services and Health, have 
been invited to comment on the proposed project, 
particularly with regard to the unit's referral 
mechanisms and admissions policies for the medi- 
cally underserved. 

Statutory Authority G.S. 131E-177(1). 

SECTION .2700 - CRITERIA AND 

STANDARDS FOR MAGNETIC 
RESONANCE IMAGEVG SCANNER 

.2702 DEFINITIONS 



The definitions in this Rule will apply to all rules 
in this S e ction: 

f4-) "Magn e tic R e sonanc e Imaging (MRI)" is 

d e fined — as — a — non invasive — diagnostic 
modality in which e l e ctronic equipment is 
us e d to cr e at e tomographic images of 
body structure. — Th e MRI unit exposes 
th e target area to nonionizing magn e tic 
en e rgy and radio fr e quency fi e lds, focus 
ing on th e nuclei of atoms such as hydro 

g e n in th e body tissue. Respons e of 

selected nuclei to this stimulus is translat 
ed — ifite — imag es — for evaluation by the 
physician. 

(3) "MRI Proc e dur e " is defin e d as a discrete 

MRI study of on e patient. 

f^3 "MRI Unit" is defined as all of the essen 

tial e quipm e nt and facilities necessary to 
op e rat e on e MRI suit e . 

(4) "Primary S e rvic e Area" is defin e d as the 

g e ographic ar e a in which 75 percent of 
the projected pati e nt population resides. 

Statutory Authority G.S 131E-177(1). 

.2703 CAPACITY' IN THE FACILITY AND 
IN THE HEALTH SERVICE AREA 

(a) A proposal to provid e n e w or e xpand e d MRI 
servic e s must b e consist e nt with th e applicable 
North Carolina Stat e H e alth Plan. 

{¥) — A proposal involving a n e w or additional 
MRI unit must s p e cify th e typ e and estimat e d 
number of oth e r diagnostic proc e dures which MRI 
will replac e or compl e m e nt in the facility. 

{e^ — A proposal involving a new or additional 
MRI unit must provid e documentation that th e 
applicant has or is d e veloping policies to establish 
th e MRI unit as a r e gional r e sourc e that will have 
no administrativ e or clinical r e quir e ments which 
would imp e de physician referrals of pati e nts for 
whom MRI t e sting would b e appropriate. — These 
polici e s mu s t pr es crib e that services or sch e dul e d 
testing will be available up to 12 hours p e r day, 
six days a w ee k as r e quir e d by th e pati e nt. 

Statutory Authority G.S. 131E-177(1). 

.2704 SCOPE OF SERVICES 

(e) — Th e proponent must d e monstrat e that the 
propos e d MRI unit will function as a compon e nt of 
a compr e h e n s iv e diagnostic imaging s e rvic e in a 
facility which curr e ntly has the following diagno s 
tic modaliti e s on site and op e rational for at least 
one year: 

<+) radioisotopic imaging studies; 



1048 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 






diagnootio X Ray otudioo; 

angiogmmo, including digital; 

diagnostio ultmoound otudi eo ; and 

comput e d tomography. 

Th e — propon e nt — must — malc e — appropriat e 



provisions for quality assuranc e and utilization 
r e vi e w in connection with MRI sorvio e s. 

Statutory Authority G.S. 131E-177(1). 

,2705 PROJECTED UTILIZATION 

A proposal to provide n e w or e xpanded magnetic 
resonanoo imaging must: 

{4^ proj e ct an annual utilization of at l e ast 

eight MR] proooduros per e ight hour ohift 
for th e first e ight cal e ndar quarters begin 
ning with th e operation of th e n e w or 
e xpand e d MRI servic e ; 

(3) initiat e MRI s e rvices no lat e r than — 1-8 

months aft e r issuanc e of th e c e rtificat e of 
need; and 

^ for th e projections provid e d in ( 1 ) of this 

Paragraph, oaloulat e the portion of proc e 
dures e xp e ct e d to b e clinical and that 
expect e d to b e for r e s e arch purposes. 
The applicant must also provid e doou 
m e ntation which — dir e ctly — r e lat e s — the 
delineation of clinical and research proce 
dures to actual discharg e or out pati e nt 
diagnos e s — r e cord e d — ifl — the — applicant's 
facility during th e most r e c e nt 12 month 
period for which this information has 
boon compil e d. 

Statutory Authority G.S. 131 £-177(1). 



qualified and authorized by th e proponent's facility 
to perform — and to — s up e rvi se magnetic — imaging 
procedur e s. Th e authorization process and crit e ria 
to b e appli e d in d e t e rmining the qualifications of 
this physician must be s p e cifi e d. 

(b) Th e propon e nt must provid e e vidence of the 
availability of two full tim e t e chnologists specially 
trained to op e rate the MRI unit. 

Statutory Authority G.S 131 E-1 77(1). 

.2710 COOPERATIVE AGREEMENTS 

Th e propon e nt must submit evidenc e of coopcra 
tiv e agr ee m e nts with — facilities — and appropriat e 
individuals to assur e e ffici e nt equipm e nt utilization 
and availability of s e rvic e . — Such evidence shall 
includ e : 

{4^ letters from appropriat e physicians indi 

eating th e ir intent to us e th e magnetic 
r e sonanc e imaging s e rvic e of th e propo 
n e nt and — te — comply — with — aH — r e l e vant 
crit e ria and guid e lines; and 

i2j d e signation of the provision s that have 

be e n — e stablish e d — te — accommodate — aH- 
referrals from oth e r faciliti e s in the pri 
mary s e rvice area. 

Statutory Authority G.S 131 E-1 77(1). 

.2711 DATA FORMAT: REPORTING 

Th e propon e nt must agr ee to shar e upon request 
validat e d r e sults of ita r e search and utilization of 
MRI with the departm e nt, in aooordanoo with data 
format and r e porting requir e m e nts that will be 
formulated by the d e partm e nt. 



.2706 SITE AND EQUIPMENT 

(a) — A proposal to provid e n e w or expand e d 
magn e tic r e sonance imaging must provid e docu 
m e ntation to show that the services will be off"er e d 
in a physical e nvironm e nt that conform s to th e 
r e quir e m e nts of f e d e ral, state and local r e gulatory 
bodies. 

(b) A propon e nt must provid e evid e nc e that th e 
propos e d MRI e quipm e nt has b e en certifi e d for 
clinical us e by th e U.S. Food and Drug Adminis 
tmtion. 

Statutory Authority G.S 131E-177(1). 

.llfSl STAFFING 

{&) The propon e nt — must hav e availabl e , — ef 

committ e d to b e availabl e , a physician lic e ns e d to 
pmotio e m e dicin e in North Carolina with evidenc e 
of training in magnetic resonanoo imaging who i s 



Statutory Authority G.S 131 E-1 77(1). 

.2713 DEFINITIONS 

The following definitions shall apply to all rules 
in this section: 

(1) "Approved MRI scanner" means an MRI 
scanner which was not operational prior 
to the beginning of the review period but 
which had been issued a certificate of 
need or had been acquired prior to March 
18, 1993 in accordance with OS^ 131E- 
175. et. al. 

(2) "Existing MRI scanner" means an MRI 
scanner in operation prior to the begin- 
ning of the review period. 

(3) "Magnetic Resonance Imaging" (MRI) 
means a non-invasive diagnostic modality 
in which electronic equipment is used to 
create tomographic images of body struc- 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1049 



PROPOSED RULES 



ture. TTie MRJ scanner exposes the 
target area to nonionizing magnetic ener- 
gy and radio frequency fields, focusing 
on the nuclei of atoms such as hydrogen 
in the body tissue. Response of selected 
nuclei to this stimulus is translated into 
images for evaluation by the physician. 

(4) "Magnetic resonance imaging scanner" 
(MRI Scanner) js defined in G.S. 13 1 E- 
176(14e). 

(5) "Mobile MRI Scanner" means an MRI 
scanner and transporting equipment 
which is moved to provide services at 
two or more host facilities. 

(6) "MRI Procedure" means a single discrete 
MRI study of one patient. 

(7) "MRI Service Area" means the geograph- 
ic area defined by the applicant. 

(8) "MRI study" means one or more scans 
relative to a single diagnosis or symptom. 

Statutory Authority G.S. 131E-177(1). 

.2714 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing to acquire a MRI 
scanner, including a Mobile MRI scanner, shall 
use the Acute Care Facility/Medical Equipment 
application form. 

(b) An applicant proposing to acquire a magnetic 
resonance imaging scanner, including a mobile 
MRI scanner, shall also provide the following 
additional information: 

(1) documentation that the MRI scanner 
shall be available for use a minimum of 
12 hours per day, six days per week. 
Mobile MRI scanners are not subject to 
this criterion; 

("2') projections of the number of procedures 
to be performed by type of service and 
the average charge for each proposed 
procedure for each of the first twelve 
quarters after completion of the project. 
TTiis information shall be provided 
separately for each proposed host facili- 
ty if the application proposes the acqui- 
sition of a mobile MRI scanner; 

(3) documentation of the need for an addi- 
tional MRI scanner in the proposed 
MRI service area and description of the 
methodology used to project need, 
including all assumptions regarding the 
population to be served; 

(A) documentation that the proposed MRI 
scanner, including a mobile MRI scan- 



£Q 
ID] 



£5) 



(61 



01 



ner, shall function as a component of a 
comprehensive diagnostic imaging 
service in a facility which has the fol- 
lowing diagnostic modalities on-site. 
The applicant shall demonstrate further 
that the following diagnostic modalities 
have been continuously available on-site 
for at least 12 months prior to the date 
the application was filed: 
radioisotopic imaging studies, 
diagnostic X-Ray studies, 
angiograms, including digital, 
diagnostic ultrasound studies, and 
computed tomography (full body); 
except for proposed MRI scanners to be 
used exclusively for research purposes, 
documentation that all equipment, 
supplies and pharmaceutical proposed 
for the service have been certified for 
clinical use by the U.S. Food and Drug 
Administration or shall be operated 
under an institutional review board 
whose membership is consistent with 
U.S. Department of Health and Human 
Service regulations; 

letters from physicians indicating their 
intent to use the proposed magnetic 
resonance imaging scanner and to com- 
ply with all relevant criteria and guide- 
lines; and 

copies of agreements that have been 
established to accommodate referrals 
from other facilities in the MRI service 



(c) An applicant proposing to acquire a mobile 
MRI scanner shall provide copies of letters of 
intent from, and proposed contracts with, all of the 
proposed host facilities of the new MRI scanner. 

Statutory Authority G.S. 131E-177(1). 

.2715 REQUIRED PERFORMANCE 
STANDARDS 

An applicant proposing to acquire a magnetic 
resonance imaging scanner, including a mobile 
MRI scanner, shall: 

(1) demonstrate that all existing MRI scan- 
ners, except mobile MRI scanners, oper- 
ating in the proposed MRI service area 
performed at least 2,032 MRI procedures 
in the last year; 

(2) project annual utilization in the third year 
of operation of at least 2,032 MRI proce- 
dures per year, for each proposed MRI 
scanner or mobile MRI scanner to be 



1050 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



15} 



operated by the applicant in the proposed 
MRI service area; 

(3) demonstrate that all of the existing MRI 
scanners operating in the proposed MRI 
service area shall be performing at least 
2,032 MRI procedures per year in the 
applicant's third year of operation; 

(4) demonstrate that all of the approved MRI 
scanners in the proposed MRI service 
area shall be performing at least 2,032 
MRI procedures per year in the 
applicant's third year of operation; 
demonstrate that all existing mobile MRI 
scanners operating in the proposed MRI 
service area performed at least an 
average of 8 procedures per day ger site 
in the proposed MRI service area in the 
last year and shall be performing at least 
an average of 8 procedures per day per 
site in the proposed MRI service area in 
the a pplicant's third year of operation; 
demonstrate that all approved mobile 
MRI scanners to be operating in the 
proposed MRI service area shall be 
performing at least an average of 8 
procedures per day per site in the 
proposed MRI service area in the 
applicant's third year of operation; and 

(7) document the assumptions and provide 
data supporting the methodology used for 
each projection required in this Rule. 

Statutory Authority G.S. 131E-177(1}. 

.IIU REQUIRED SUPPORT SERVICES 

(a) An applicant proposing to acquire a magnetic 
resonance imaging scanner, including a mobile 
MRI scanner, shall provide the following on-site 
services and specialists or shall provide formal 
referral agreements that ensure that the following 
services are otherwise available: 



£6} 



m 

£21 

m 

£4} 
£51 
£61 
£71 
£81 
£9] 



anesthesiology, 
radiology, 
oncology, 
neurology, 
internal medicine. 



orthopedics, 

neurosurgery, 

pathology, and 

surgery. 

(b) An applicant proposing to acquire a mobile 
MRI scanner shall provide referral agreements 
between each host site and at least one other 
provider of MRI services in the proposed MRI 
service area to document the availability of MRI 



services if patien ts require them when the mobile 
unit is not in service at that host site. 

Statutory Authority G.S 131E-177(1). 

.2717 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) The a pplicant shall document that the 
proposed MRI scanner shall be operated under the 
supervision of a medical director who shall be a 
North Carolina licensed radiologist, nuclear 
medicine imaging physician, or other physician 
whose primary responsibility for the three years 
immediately prior to the date of the filing of the 
application has been the interpretation of images. 
This physician shall have knowledge of MRI 
through training, experience, or documented post- 
graduate education. An applicant for an MRI 
scanner shall identify one or more qualified 
physicians who are interested in becoming, or are 
available to serve as, medical director. 

(b) The applicant shall provide evidence of the 
availability of two full-time MRI technologist- 
radiographers or technologists who have had 
equivalent education, training, and experience. 
One of the technologists shall be on-site at all 
times during operating hours. This individual shall 
demonstrate experience in computed tomography, 
nuclear medicine or other cross-sectional imaging 
methods. 

(c) TTie applicant shall submit documentation 
which demonstrates the availability of appropriate 
inservice training or continuing education 
programs for all staff". 

(d) The applicant shall submit documentation 
which demonstrates that at least one staff" member 
who is certified \n CPR and basic cardiac life 
su pport shall be present in the facility at all times. 

Statutory Authority G.S 131E-177(1). 

.2718 ACCESSIBILITY 

(a) An applicant that proposes to acquire a 
magnetic resonance imagmg scanner, including a 
mobile MRI scanner, shall provide documentation 
describing the mechanism that will be used to 
assure that the projected number of medically 
underserved will be served in the facility. 

(b) The applicant shall provide written 
admissions policies identifying any prepayment or 
deposit requirements which states the admissions 
requirements for the following payor categories: 

(1) Medicare; 
£21 Medicaid; 
£3} Blue Cross and Blue Shield; 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1051 



PROPOSED RULES 



(41 
(5) 
16} 

ill 



Commercial Insurance; 

State Employees Health Plan; 

Self-Pay (includes self-pay, indigent 

and charity care); and 

Other as identified by the applicant. 

(c) The applicant shall provide a written descrip- 
tion of the billing procedures, including the credit 
and collection policies that will be utilized by the 
facility. 

(d) The applicant shall document that the health 
care community in the service area, including the 
Departments of Social Services and Health, have 
been invited to comment on the proposed project, 
particularly with regard to the facility's referral 
mechanisms and admissions policies for the medi- 
cally underserved. 

Statutory Authority G.S. 131E-177(1). 

.2719 DATA REPORTING REQUIREMENTS 

The applicant shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information, in accor- 
dance with data format and reporting requirements 
formulated by the Division of Facility Services: 

(1) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S 131 E-1 77(1). 

SECTION .3100 - CRITERIA AND 

STANDARDS FOR MAJOR MEDICAL 

EQUIPMENT 

.3101 PURPOSE AND SCOPE 

TTie rules set forth in this Section shall apply to 
applications for major medical equipment, includ- 
ing new major medical technology, for which 
specific criteria and standards have not otherwise 
been promulgated in 10 NCAC 3R. 

Statutory Authority G. S 131 E-1 77(1). 

.3102 DEFEVITIONS 

The following definitions shall apply to all rules 
in this Section: 

( 1 ) "Essential" means those items which are 
indispensable, the absence of which 
renders the equipment useless. 

(2) "Major Medical Equipment" is defined in 
G.S. 131E-176(14f). 

(3) "Mobile Major Medical Equipment" 
means major medical equipment and 
transporting equipment which is moved 



to provide services at two or more host 
facilities. 
(4) "New Major Medical Technology" means 
major medical equipment that: 

(a) has been approved for clinical use by 
the U.S. Food and Drug Administration 
or shall be operated in accordance with 
protocols appro\ed by an institutional 
review board whose membership is 
consistent with the U.S. Department of 
Health and Human Services regulations; 

(b) is intended for use in tlie diagnosis or 
treatment of medical conditions; 

(c) which meets the definition of major 
medical equipment in G.S. 13 lE- 
176(14f); 

(d) which is so new that no state or nation- 
al utilization data is readily available to 
the Agency for the development of 
specific criteria and standards. 

Statutory Authority G.S. 131 E-1 77(1). 

.3103 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing to acquire new major 
medical technology or major medical equipment 
shall use the Acute Care Facility/Medical Equip- 
ment application form. 

(b) An applicant shall define a proposed service 
area for the major medical equipment or new 
major medical technology which shall be similar to 
the applicant's existing service area for other 
health services, unless the applicant documents that 
other providers outside of tlie applicant's existing 
service area are expected to refer patients to the 
applicant. 

(c) An applicant shall document its current 
experience in providing care to the patients to be 
served by the proposed major medical equipment 
or new major medical technology. 

(d) An applicant shall document the estimated 
productive life of tlie specific equipment and 
whether any improvements can be expected during 
its productive life that would reduce its capital 
cost, operating cost, or increase ns productivity. 

(e) An applicant shall document that the pro- 
posed new major medical technology or major 
medical equipment, its supplies, and its pharm- 
aceuticals have been approved by the U.S. Food 
and Drug Administration for the clinical uses 
stated in the application, or that the equipment 
shall be operated under protocols of an institutional 
review board whose membership is consistent with 
the LL S^ Department of Health and Human 



1052 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



Services regulations. 

(f) An a pplicant proposing to acquire new major 
medical equipment or new major medical technolo- 
gy shall provide a floor plan of the facility ]n 
which the equipment will be operated that 
identifies the following areas: 

(1) receiving/registering area; 

waiting area; 

pre-procedure area; 

procedure area or rooms: 

post-procedure areas. 



£3} 
141 
15} 



including 



observation areas; and 
(6) administrative and support areas, 
(g) An applicant proposing to acquire major 
medical equipment or new major medical 
technology shall document that the facility shall 
meet or exceed the appropriate building codes and 
standards for the type of major medical equipment 
to be installed. 



£5} 



major medical technology may have on 
existing major medical technology and 
procedures off'ered at its facility and 
other facilities in the proposed service 
area; and 

all the assumptions and data supporting 
the methodology used for the projec- 
tions in this Rule. 



Statutory Authority G.S. 131E-177(1). 

.3105 REQUIRED SUPPORT SERVICES 

An a pplicant proposing to acquire major medical 
equipment or new major medical technology shall 
identify all ancillary and support services that are 
required to support the major medical equipment 
or new major medical technology and shall docu- 
ment that all of these services shall be available 
prior to the operation of the equipment. 



Statutory Authority G.S 131E-177(1). 

.3104 NEED FOR SERVICES 

(a) An applicant proposing to acquire major 
medical equipment shall provide the following 
information: 

(1) the number of patients who will use the 
service, classified by diagnosis and by 
county of residence; 
(T) documentation of the maximum number 
of procedures that existing equipment 
that is used for similar procedures in 
the facility is capable of performing; 
("3) quarterly projected utilization of the 
applicant's existing and proposed 
equipment three years after the 
completion of the project; and 
(4) all the assumptions and data supporting 
the methodology used for the 
projections in this Rule. 
(Tj) An applicant proposing to acquire new major 
medical technology shall provide the following 
information: 

(1) the number of patients who will use the 
service, classified by diagnosis and by 
county of residence; 

(2) quarterly projected utilization of the 
applicant's proposed new major medi- 
cal technology three years after the 
completion of the project; 

(3) documentation that the applicant's 
utilization projections are based on the 
experience of the provider and on 
epidemiological studies; 

(4) documentation of the eff'ect the new 



Statutory Authority G.S 131E-177(1). 

.3106 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) An applicant proposing to acquire major 
medical equipment or new major medical technolo- 
gy shall document that: 

(1) trained and qualified clinical staff shall 
be employed, and 

(2) trained technical stafl^ and support 
personnel to work in conjunction with 
the operators of the equipment shall be 
employed. 

(b) An applicant proposing to acquire major 
medical equipment or new major medical technolo- 
gy shall provide documentation that physicians 
who will use the equipment have had relevant 
residency training, formal continuing medical 
education courses, and prior on-the-job experience 
with this or similar medical equipment. 

(c) An applicant shall demonstrate that the 
following stafi" training will be provided to the 
stafF that operates the major medical equipment or 
new major medical technology: 

(1) certification in cardiopulmonary resus- 
citation and basic cardiac life support; 
and 

(2) an organized program of staff " education 
and training which is integral to the 
operation of the major medical equip- 
ment and ensures improvements in 
technique and the proper training of 
new personnel. 

Statutory Authority G.S. 131 £-177(1). 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1053 



PROPOSED RULES 



.3107 ACCESSIBILITY 

(a) The applicant shall provide documentation 
describing the mechanism that will be used to 
insure that the projected number of medically 
underserved will be served by the major medical 
equipment. 

(b) The applicant shall provide written admis- 
sions policies identifying any prepayment or 
deposit requirements for the major medical equip- 
ment and stating the admission requirements for 
patients in each of the following payor categories: 



m 

12} 
Oi 
i^ 
15} 
16} 



Medicare; 

Medicaid; 

Blue Cross and Blue Shield; 

Commercial Insurance; 



indigent 



01 



State Employees Health Plan; 
Self- Pay (includes self-pay, 
and charity care); and 
Other as identified by the applicant. 

(c) The applicant shall provide a written descrip- 
tion of the billing procedures, including the credit 
and collection policies that will be utilized by the 
major medical equipment. 

(d) The applicant shall document that the health 
care community in the service area, including the 
Departments of Social Services and Health, have 
been invited to comment on the proposed project, 
particularly with regard to the referral mechanisms 
and admissions policies for the medically under- 
served. 

Statutory Authority G.S. 131E-177(1). 

.3108 DATA REPORTING 
REQUIREMENTS 

The applicant shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information, in accor- 
dance with data format and reporting requirements 
formulated by the Division of Facility Services: 

(1) demographic data on patients treated: 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S. 131E-177(1). 

SECTION .3200 - CRITERIA AND STAN- 
DARDS FOR LITHOTRIPTOR EQUIPMENT 

.3201 DEFINITIONS 

The following definitions shall apply to all rules 
in this Section: 

(1) "Approved lithotriptor" means a 
lithotriptor which was not operational 
prior to the beginning of the review 



18} 



means 
to 



a 
the 



period but which had been issued a 
certificate of need or had been acquired 
prior to March 18, 1993 in accordance 
with G.S. 131E-175, et. al. 

£2} "Complicated stone disease treatment 
capability" means the expertise necessary 
to manage all patients during the 
treatment of kidney stone disease. This 
includes but is not limited to a urologist 
skilled and experienced in both 
percutaneous and retrograde endoscopic 
stone removal procedures, and 

experienced interventional radiologic 
support. 

"Existing lithotriptor" 
lithotriptor in operation prior 
beginning of the review period. 
"Host facility" means the site at which a 
mobile lithotriptor is parked for the 
provision of SWL procedures. 
"Lithotriptor" means equipment as 
defined in G.S. 131E-176(14d). 
"Lithotriptor service area" means a 
geographical area defined by the 
a pplicant and which has boundaries that 
encompass at least 1,000,000 of the 
state's residents. 

(7) "Mobile lithotriptor" means a lithotriptor 
and transporting equipment that is moved 
to provide services at two or more host 
facilities. 

"Shock wave lithotripsy (SWL) 
procedure" means a procedure for the 
removal of kidney stones which involves 
focusing shock waves on kidney stones so 
that they are pulverized into sand-like 
particles which may then be passed 



£3} 
14} 

£5} 
16} 



through the urinary tract. 

Statutory Authority G.S. 131E-177(1). 

.3202 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing to acquire a 
lithotriptor shall use the Acute Care 
Facility/Medical Equipment application form. 

(b) An applicant proposing to acquire a 
lithotriptor shall also provide the following 
additional information: 

of 



m 

12} 



the boundaries 



the proposed 



lithotriptor service area; 
documentation that 1,000.000 persons 
reside in the proposed lithotriptor 
service area based on population data 
provided by the North Carolina State 



1054 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



Office of Management and Budget; 

(3) documentation that all equipment. 
su pplies and pharmaceuticals proposed 
for the service have been certified for 
clinical use by the U.S. Food and Drug 
Administration or will be operated and 
used under an institutional review board 
whose membership is consistent with 
U.S. Department of Health and Human 
Services regulations; 

(4) the number of patients from the 
proposed lithotriptor service area who 
are projected to receive SWL 
procedures by patient's county of 
residence in each of the first 12 
quarters after completion of the project. 
This information shall be provided 
separately for each proposed host 
facility in those applications which 
propose the acquisition of a mobile 
lithotriptor; 

(5) documentation from the applicant's 
projected referral sources which 
indicates their intent to refer to the 
applicant's lithotriptor; and 

(6) the locations at which existing and 
approved lithotriptor, including mobile 
units, operate or have been approved to 
operate in the lithotriptor service area. 

(c) An applicant proposing to acquire a mobile 
lithotriptor shall also provide the following 
information: 

(1) copies of letters of intent from, and 
proposed contracts with, all of the 
proposed host facilities; 

(2) the proposed schedule for the provision 
of SWL procedures at each host 
facility; 

(3) the projected method for staffing the 
service, including whether personnel 
will travel with the lithotriptor or will 
be supplied at each host facility where 
services are provided and whether 
personnel will be dedicated to providing 
lithotriptor services; and 

(4) documentation of the means by which 
patients will receive follow-up care 
after the lithotriptor leaves the site 
where the services are provided. 

Statutory Authority G.S. 131E-177(1). 

.3203 REQUIRED PERFORMANCE 
STANDARDS 

An applicant proposing to acquire a lithotriptor. 



including a mobile lithotriptor. shall demonstrate 
that the following standards are met: 
(1) each existing lithotriptor in the proposed 

lithotriptor service area, except mobile 

lithotriptors. performed 1 .000 procedures 

in the last year; 

each proposed lithotriptor shall be 



(2} 



m 



14) 



15} 



projected to perform 1.000 procedures 
per year in the third year of operation of 
the proposed lithotriptor; 
each existing and approved lithotriptor, 
except mobile lithotriptors. in the 
proposed lithotriptor service area shall be 
projected to perform at least 1000 
procedures per year in the third year of 
operation of the proposed lithotriptor; 
each existing mobile lithotriptor 
providing services in the proposed 
lithotriptor service area performed an 
average of 4^ procedures per day per 
site in the proposed lithotriptor service 
area; 

each existing and approved mobile 
lithotriptor providing services in the 
proposed lithotriptor service area shall 
perform an average of 4.0 procedures per 
day per site in the proposed lithotriptor 
service area in the applicant's third year 
of operation. 



Statutory Authority G.S. 131E-177(1). 

.3204 REQUIRED SUPPORT SERVICES 

(a) An applicant proposing to acquire a 
lithotriptor shall document the availability of the 
following services: 

(1) an active radiology service and an 
established referral urological practice; 
and 

(2) the availability and accessibility of 
acute inpatient services for patients who 
experience complications. 

(b) An applicant proposing to acquire a mobile 
lithotriptor shall provide referral agreements 
between each host site and at least one other 
provider of lithotriptor services m the proposed 
lithotriptor service area to document the 
availability of lithotriptor services jf patients 
require them when the mobile lithotriptor is not in 
service at that host facility. 

Statutory Authority G.S. 131E-177(1). 

.3205 REQUIRED STAFFING AND STAFF 
TRAINING 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1055 



PROPOSED RULES 



(a) The applicant shall demonstrate that the 
following staff shall be available at each location 
at which the lithotriptor will be operated: 



lii 
12} 



one certified general surgeon; 
one certified urologist skilled 



and 



Ql 



experience in complicated stone disease 
treatment capability; and 
one certified radiologist with experience 
in X-ray, CT and Ultrasound Imaging. 

(b) All individuals using the lithotriptor 
equipment shall meet the training and proficiency 
guidelines and standards in the American 
Urological Association Guidelines and Standards, 
which are hereby incorporated by reference, 
including all subsequent amendments and editions 
of the referenced materials. A fist of the 
American Urological Association's approved 
training sites may be obtained free of charge from 
American Urological Association, 1 120 North 
Charles Street, Baltimore, Maryland. 2 1 20 1 . 

(c) The a pplicant shall demonstrate that the 
following staff" training shall be provided at each 
location where the lithotriptor will be operated: 

(1) certification in cardiopulmonary resus- 
citation and basic cardiac life support; 
and 

(2) an organized program of staff" education 
and training specific to lithotriptor 
services that ensures improvements in 
technique and the proper training of 
new personnel. 

Statutory Authority G.S. I3IE-I77(1). 

.3206 DATA REPORTING REQUIREMENTS 

The applicant oflTering lithotriptor services shall 
agree to provide, upon the request of the Division 
of Facility Services, the following types of data 
and information, in accordance with data format 
and reporting requirements formulated by the 
Division of Facility Services: 

(1) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S 131 £-177(1). 

.3207 ACCESSIBILITY 

(a) The applicant shall provide documentation 
describing the mechanism that will be used to 
insure that the projected number of medically 
underserved will be served in the facility. 

(b) The applicant shall provide written admis- 
sions policies identifying any prepayment or 
deposit requirements for the facility and stating the 



admission requirements for patients in each of the 
following payor categories: 

(1) Medicare; 

(2) Medicaid; 

(3) Blue Cross and Blue Shield; 

(4) Commercial Insurance; 

(5) State Employees Health Plan; 

(6) Self- Pay (includes self-pay, indigent 
and charity care); and 

(7) Other as identified by the applicant. 

(c) The applicant shall provide a written descrip- 
tion of the billing procedures, mcluding the credit 
and collection policies that will be utilized by the 
facility. 

(d) The applicant shall document that the health 
care community in the service area, including the 
Departments of Social Services and Health, have 
been invited to comment on the proposed project, 
particularly with regard to the facility's referral 
mechanisms and admissions policies for the medi- 
cally underserved. 

Statutory Authority G.S 131E-177(1). 

SECTION .3300 - CRITERIA AND 
STANDARDS FOR AIR AMBULANCE 

.3301 DEFENrtTIONS 

The following definitions shall apply to alj rules 
in this Section: 

(1) "Air ambulance" as defined in G.S. 
131E-176(la). 

(2) "Air ambulance service" means an entity 
engaged in the operation of an air ambu- 
lance transporting patients. 

(3) "Air ambulance service area" means a 
geographic area defined by the applicant 
from which the project's patients origi- 
nate. 

(4) "Approved air ambulance" means either 
a rotary air ambulance or a fixed wing 
air ambulance which was not operational 
prior to the beginning of the review 
period but which had been acquired prior 
to March 18, 1993 in accordance with 
G.S. 131E-175. et. al. 

(5) "Audit and review panel" as defined in 
21 NCAC 32H .0100. 

(6) "Capacity of fixed wing air ambulance" 
means the maximum number of hours the 
aircraft can be operated as defined by the 
aircraft manufacturer. 

(7) "Category IV £A] ambulance" as defined 
in 10 NCAC 3D .0801(b)(4)(A). 

(8) "Category IV (B) ambulance" as defined 



1056 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



m 



am 



Oil 
(12) 

£13} 
(14) 
(15) 



(16) 

(17) 



in 10 NCAC 3D .0801(b)(4)(B). 
"Existing air ambulance" means either a 
rotary air ambulance or a fixed wing air 
ambulance in operation prior to the be- 
ginning of the review period. 
"Ground mobile intensive care ambulance 
service" means a ground based emergen- 
cy vehicle that meets the definition of a 
'mobile intensive care unit' as defined in 
21 NCAC 32H .0100. 
"Inter-facility patient transport" means 
the transport of a patient from one facili- 
ty to another facility. 
"Level 2 trauma center" as defined in 
North Carolina's Trauma Center Criteria 
developed by the OEMS pursuant to G.S. 
131E-162(7a). 

"Medical crew member" as defined in 10 
NCAC 3D .0800. 

defined 



"Medical 



as 



in 21 



18) 



director" 

NCAC 32H .0100. 

"Office of Emergency Medical Services" 

(OEMS) as defined m fO NCAC 3D 

■0800 and 21 NCAC 32H .0100. 

"Patient" as defined in G.S. 131E-155(6). 

"Scene transport" means the transport of 

a patient from the scene of a medical 

emergency. 

"Sponsor hospital" as defined in 21 

NCAC 32H .0102. 



Statutory^ Authority G.S. 131E-177(1). 

.3302 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing to acquire an air 
ambulance shall use the Acute Care 
Facility/Medical Equipment Application Form. 

(b) The applicant shall also provide the follow- 
ing additional information: 

(1) the number of air ambulance aircraft by 
type and make currently operated and 
to be operated in the "air ambulance" 
service area following completion of the 
proposed project; 

(2) if the applicant js a current air ambu- 
lance service provider, documentation 
of the applicant's experience in trans- 
porting patients via air ambulance 
during the past 12 months, including: 

(A) the number of scene transports by air 
ambulance by type of air ambulance 
(i.e.. fixed wing and rotary wing); 
and 

(B) the number of inter-facility patient 



141 



transports by air ambulance by type 

of air ambulance (i.e.. fixed wing and 

rotary wing); 

(3) if the applicant is a health service facili- 

ty proposing to establish a new air 

ambulance service, the applicant shall 

provide documentation of: 

(A) the number of scene transports to 
their facility by air ambulance by type 
of air ambulance (i.e., fixed wing and 
rotary wing) during the past 12 
months; and 

(B) the number of inter-facility patient 
transports during the past 12 months 
by air ambulance by type of air ambu- 
lance (i.e.. fixed wing and rotary 
wing) to their facility from other 
facilities and from their facility to 
other facilities; 

the number of patients from the pro- 
posed air ambulance service area that 
are projected to require air ambulance 
service by type of aircraft and the 
patient's county of residence and county 
from which transported in each of the 
first 12 calendar quarters of operation 
following completion of the project, 
including the methodology and assump- 
tions used for the projections; 
the projected utilization of the air am- 
bulance service per aircraft for each of 
the first 12 calendar quarters following 
completion of the proposed project by 
type of patient (e.g.. neonatal, pediat- 
ric, cardiac), including the methodology 
and assumptions used for these projec- 
tions; 

documentation which demonstrates that 
existing air ambulance services in the 
State are unable to accommodate the 
applicant's projected need for an addi- 
tional air ambulance; 



15} 



£6] 



m 



£8] 



£9) 



as appropriate to the type of aircraft 
proposed, documentation of referral 
sources for air ambulance patients and 
evidence of the willingness of hospitals 
to participate; 

documentation which demonstrates the 
applicant's capability to communicate 
with and access emergency transporta- 
tion resources including, but not limited 
to ground mobile intensive care ambu- 
lance services; 

evidence of the applicant's capability to 
provide air ambulance services on a 24 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1057 



PROPOSED RULES 



hour per day, 7 day per week basis 
except as precluded by weather, mainte- 
nance and other factors as applicable; 
10) documentation of appropriate inservice 
training or continuing education pro- 
grams for staff; 
1 U documentation of written policies and 
procedures for the operation of the air 
ambulance service, which shall be in 
effect at the time the proposed air 
ambulance becomes operational, for at 
least the following: 
(A) arrangements for transport of a patient 
when patient transport cannot be 
provided by the applicant or a current 
Mutual Aid Agreement with the NC 
Aeromedical Af^liation and other 
agreements as appropriate with ad- 
joining states; 

written criteria for patient transport; 
medical crew contact with medical 



m 

mi 

mi 

ID 
£G1 



of an audit and review 



control; 
operation 
panel; 

patient treatment protocols; 
patient transfer protocols; 
communication, including incoming 
calls, dispatch, and on-going commu- 
nication with air ambulance flight and 
medical crew and other emergency 
medical service providers; 

(H) role in disaster plans; 

(I) if the applicant proposes a Category 
IV (A) ambulance, the proposed role 
and responsibility of participating 
hospitals as outlined jn 2\_ NCAC 
32H; 

(J) if the applicant proposes a Category 
IV £A1 ambulance, medical control as 
outlined in 21 NCAC 32H; and 

(K) coordination with local emergency 
medical service systems m the pro- 
posed air ambulance service area or 
other providers as appropriate given 
the type of aircraft and service pro- 
posed; 
(12) if the applicant is an existing air ambu- 
lance service provider, copies of the 
following, as applicable: 

(A) the current permit(s) issued by the 
OEMS and evidence that the permit(s) 
has not been denied or revoked. 

(B) the current FAA Part 135 or Part 91 
Certificate, and 

(C) the current FCC radio license; 



(13) if an applicant does not currently oper- 
ate an air ambulance, evidence that the 
OEMS. FCC and FAA are aware of the 
proposed air ambulance and that the 
applicant expects to be able to obtain all 
required permits, licenses or certifica- 
tions and an indication of the category 
of ambulance proposed, i.e.. Category 
IV (A) or Category IV (B) ambulance; 

(14) documentation of the aircraft selection 
analysis used by the applicant and 
reason for selection of the aircraft 
proposed; 

(15) documentation of a financial analysis of 
a lease versus purchase option for 
acquisition of the proposed aircraft and 
the method (e.g.. hire own versus 
contract) of providing personnel to fly 
the aircraft and the reason for selection 
of the option proposed; 

(16) if the applicant proposes a Category IV 
(A) ambulance, evidence of the exis- 
tence of a sponsor hospital that meets 
criteria set forth in 2\ NCAC 32H; and 

(17) if the applicant proposes the acquisition 
of a fixed wing air ambulance, docu- 
mentation of the capacity of each exist- 
ing fixed wing air ambulance based in 
the state. 

Statutory Authority G.S. 1 31 E- 177(1). 

.3303 REQUIRED PERFORMANCE 
STANDARDS 

An applicant proposing to acquire an air ambu- 
lance shall demonstrate that the project meets the 
following standards: 
(1) For the acquisition of a rotary air ambu- 
lance (unless 10 NCAC 3R .3303(4) is 
applicable): 

(a) existing rotary air ambulances based in 
the State of North Carolina shall have 
flown an average of 60 patient flights 
per month per rotary aircraft for the 
last year [calculated as follows: (total 
number of patient flights In the jast year 
flown in the state by rotary air ambu- 
lances based in the state) divided by 
(total number of rotary air ambulances 
based in the state) divided by (twelve)l; 
and 

(b) each rotary air ambulance proposed to 
be acquired by the applicant shall be 
utilized at an average rate of at least 60 
patient requests per month, measured 



1058 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



during the fourth quarter of the second 
year following completion of the project 
(the a pplicant shall document the as- 
sumptions and provide data su pporting 
the methodology used for the projec- 
tions); and 

(c) existing or approved rotary air ambu- 
lances based in the state are projected 
to be utilized at an average of no less 
than 60 patient requests per month per 
rotary aircraft measured during the 
fourth quarter of the third year after the 
operation of the new air ambulance 
[calculated as follows: (total projected 
number of patient requests in the fourth 
quarter of the third year after the opera- 
tion of the new air ambulance by exist- 
ing or approved rotary air ambulances 
based in the state) divided by (total 
number of existing or a pproved rotary 
air ambulances based in the state in the 
fourth quarter of the third year after the 
operation of the new air ambulance) 
divided by (three)1 (the applicant shall 
document the assumptions and provide 
data supporting the methodology used 
for the projections); and 

(d) an applicant proposing to add a rotary 
air ambulance to an existing rotary air 
ambulance service shall demonstrate 
that all of its existing rotary air ambu- 
lances have had at least 60 patient 
requests per month in the last year. 

(2) For the acquisition of a fixed wing air 
ambulance (unless 10 NCAC 3R .3303(4) 
is applicable): 

(a) existing fixed wing air ambulances 
based in the State of North Carolina 
were utilized at an average of 60% of 
capacity transporting patients for the 
last year [calculated as follows: (total 
utilized capacity transporting patients in 
the last year of fixed wing air ambu- 
lances based in the state) divided by 
(total potential capacity of fixed wing 
air ambulances based in the state in the 
last year) times (100)1; and 

(b) each fixed wing air ambulance proposed 
to be acquired by the applicant shall be 
utilized at an average of no less than 
60% of capacity transporting patients 
(determined based on the type aircraft), 
measured during the fourth quarter of 
the second year following completion of 
the project (the applicant shall docu- 



ment the assumptions and provide data 
supporting the methodology used for 
the projections); and 

(c) existing or a pproved fixed wing air 
ambulances based in the state are not 
projected to fel] below an average 60% 
of capacity transporting patients mea- 
sured during the fourth quarter of the 
third year after the operation of the new 
air ambulance [calculated as follows: 
(total projected utilized capacity trans- 
porting patients in the fourth quarter of 
the third year after the operation of the 
new air ambulance of existing or ap- 
proved fixed wing air ambulances based 
in the state) divided by (total potential 
capacity of existing or approved fixed 
wing air ambulances based in the state 
in the fourth quarter of the third year 
after the operation of the new air ambu- 
lance) times (lOO)l(the applicant shall 
document the assumptions and provide 
data supporting the methodology used 
for the projections); and 

(d) an applicant proposing to add a fixed 
wing air ambulance to an existing fixed 
wing air ambulance service shall dem- 
onstrate that all of Its existing fixed 
wing air ambulances have been utilized 
at no less than 60% of capacity trans- 
porting patients for the last year. 

(3) For all proposed projects involving the 
development of a new air ambulance 
service (rotary or fixed wing), the new 
service shall be developed in conjunction 
with at least a level 2 designated trauma 
center and another air ambulance service 
shall not be based within 60 air miles of 
the base of the proposed new service. 

(4) For acquisition of an air ambulance that 
shall be utilized less than 25% of the 
time flown for purposes defined in G.S. 
131E-176(la), the applicant shall provide 
the following information: 

(a) documentation that the aircraft shall be 
utilized less than 25% of the time flown 
in any given quarter for purposes de- 
fined in OS, I31E-I76(la) (the appli- 
cant shall document the assumptions 
and provide data supporting the meth- 
odology used for the projections); and 

£b) a detailed description of all circum- 
stances and conditions under which the 
aircraft will be utilized including the 
number of hours the aircraft will be 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1059 



PROPOSED RULES 



flown for each of these circumstances; 
and 

(c) if the proposal js for a rotary wing 
aircraft, existing rotary air ambulances 
based in the State are projected to be 
utilized at an average of no less than 60 
patient requests per month per rotary 
aircraft measured during the fourth 
quarter of the first year after the opera- 
tion of the new air ambulance [calculat- 
ed as follows: (total projected number 
of patient requests in the fourth quarter 
of the first year after the operation of 
the new air ambulance by existing or 
approved rotary air ambulances based 
in the state) divided by (total number of 
existing or approved rotary air ambu- 
lances based jn the state in the fourth 
quarter of the first year after the opera- 
tion of the new air ambulance) divided 
by (three)] (the applicant shall docu- 
ment the assumptions and provide data 
supporting the methodology used for 
the projections); and 

(d) if the proposal js for a fixed wing air 
ambulance, the utilization of existing 
fixed wing air ambulances based in the 
State are not projected to fell below an 
average 60% of capacity transporting 
patients measured during the fourth 
quarter of the first year after the opera- 
tion of the new air ambulance [calculat- 
ed as follows: (total projected utilized 
capacity transporting patients in the 
fourth quarter of the first year after the 
operation of the new air ambulance of 
existing or approved fixed wing air 
ambulances based in the state) divided 
by (total potential capacity of existing 
or approved fixed wing air ambulances 
based in the state in the fourth quarter 
of the first year after the operation of 
the new air ambulance) times (l(X))1(the 
applicant shall document the assump- 
tions and provide data supporting the 
methodology used for the projections). 

Statutory Authority G.S. 13]E-177(1). 

.3304 REQUIRED SUPPORT 

SERVICES/EQUIPMENT 

(a) The applicant shall demonstrate that the 
following services or equipment shall be available 
on a 24 hour per day, 7 day per week basis: 

(1) two-way voice radio licensed by the 



ill 
14] 



FCC that meets the capabilities outlined 
in 10 NCAC 3D; 

internal voice communication system as 
outlined in 10 NCAC 3D; 



aircraft and patient compartment that 
meet standards of 10 NCAC 3D; and 
equipment as outlined in JO NCAC 3D. 
(b) The applicant shall demonstrate that a com- 
munity outreach and aircraft related accident 
prevention education program shall be provided on 
an ongoing basis. 

Statutory Authority G.S 131E-177(1). 

.3305 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) The applicant shall demonstrate that the 
following staff shall be available to provide air 
ambulance services: 



ill 



(2) 



a North Carolina licensed physician 
who is designated as the medical direc- 
tor and who meets the requirements of 
21 NCAC 32H; 

medical crew members trained in accor- 
dance with 10 NCAC 3D and available 
in accordance with 10 NCAC 32H; 



(3) flight crew members to fly the aircraft 
in accordance with 10 NCAC 3D; 

(4) if applicable, personnel available as 
needed for transport of special care 
patients (e.g., neonatal, cardiac); 

(5) appropriately trained personnel to oper- 
ate the ground communication network. 

(b) TTie applicant shall provide an organized 
program of staff education and training approved 
by the OEMS which is integral to the air ambu- 
lance service and ensures improvements in tech- 
nique and the proper training of personnel includ- 
ing flight and medical crew members as required 
by 10 NCAC 3D and 21 NCAC 32H. 

Statutory Authority G.S 131E-177(1). 

.3306 DATA REPORTESfG REQUIREMENTS 

The applicant shall provide, upon the request of 
the Division of Facility Services, the following 
types of data and information, m accordance with 
data format and reporting requirements formulated 
by the Division of Facility Services: 

(1) demographic data on patients transported; 

(2) financial data; and 

(3) clinical data. 

Statutory' Authority G.S 131E-177(1). 



1060 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



SECTION .3400 - CRITERIA AND STAN- 
DARDS FOR BURN INTENSIVE CARE 
SERVICES 

.3401 DEFINITIONS 

The following definitions shall apply to all rules 
in this Section: 

(1) "Approved bum intensive care unit" 
means a bum intensive care unit which 
was not operational prior to the beginning 
of the review period but which had been 
issued a certificate of need or had been 
acquired prior to March 18, 1993 in 
accordance with G.S. 131E-175, et. al. 

(2) "Bum care technician" means: 
(a) a licensed practical nurse; 
(h) a operating room technician; 

(c) a operating room corpsman; or 

(d) a high school graduate with basic nurse 
aide training who has received special 
education or experience in bum treat- 
ment care. 

(3) "Bum intensive care services" as defined 
in G.S. 131E-176(2b). 

(4) "Bum intensive care service area" means 
a geographic area defined by the appli- 
cant from which the patients to be admit- 
ted to the unit will originate. 

(5) "Bum intensive care unit" means a desig- 
nated area within a hospital dedicated to 
the provision of burn intensive care 
services to severely bumed patients. 

(6) "Bum specialist" means a registered 
nurse who possesses experience in gener- 
al nursing and experience in or knowl- 
edge of intensive nursing care and bum 
treatment care. 

(7) "Existing bum intensive care unit" means 
a bum intensive care unit in operation 
prior to the beginning of the review 
period. 

(8) "Severely bumed patient" means a patient 
that has bums covering more than 20 
percent of the body area or that has burns 
which require intensive treatment, such 
as, but not limited to: inhalation injuries; 
chemical and electrical burns; burns with 
complications, such as fractures; burns to 
the face; full thickness bums to the hands 
and feet; bums on patients whose pre- 
burned health was known to be poor, 
such as patients with diabetes or heart 
disease; and, bums on patients who are 
under 5 and over 60 years of age. 



Statutory Authority G.S. 131E-177(1). 

.3402 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing to develop a new 
bum intensive care unit or to add beds to an 
existing or approved burn intensive care unit shall 
use the Acute Care Facility/Medical Equipment 
application form. 

(b) An applicant proposing to develop a new 
bum intensive care unit or to add beds to an 
existing or approved bum intensive care unit shall 
also provide the following additional information: 



m 



12} 



lA] 



the number of beds in the bum inten- 
sive care unit currently operated in the 
a pplicant's facility and the total to be 
operated following completion of the 
proposed project; 

documentation of the applicant's experi- 
ence in treating severely bumed patients 
at its facility during the last year, in- 
cluding: 
the number of severely bumed pa- 
tients treated through emergency 
room services; 



(B) the number of severely bumed pa- 
tients referred to the applicant's facili- 
ty from other facilities; 

(C) the number of inpatient days of care 
provided to severely bumed patients; 
and 

(D) the number of severely bumed pa- 
tients the applicant referred to other 
facilities for bum treatment; 

(3) the number of severely bumed patients 
from the proposed burn intensive care 
service area that are projected to re- 
quire bum intensive care services, by 
the patient's county of residence, in 
each of the first 12 quarters of opera- 
tion following completion of the pro- 
ject. The ap plicant shall state the meth- 
odology and assumptions used to make 
the projections; 

(4) the projected utilization of the beds iji 
the applicant's bum intensive care unit 
for each of the first twelve calendar 
quarters following completion of the 
proposed project, including the method- 
ology and assumptions used for these 
projections; 

(5) evidence that existing and approved 
bum intensive care units in the state are 
unable to accommodate the applicant's 
projected need for additional bum 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1061 



PROPOSED RULES 



intensive care services; 

(6) letters from physicians or other evi- 
dence that document the referral sourc- 
es of patients to the bum intensive care 
unit; 

(7) evidence of the applicant's capability to 
communicate with and access emergen- 
cy transportation resources including . 
but not limited to air ambulance servic- 
es; 

(8) evidence of the applicant's capability to 
provide bum treatment services in the 
bum intensive care service unit on a 24 
hour per day. 7 day ^er week basis; 

(9) description of inservice training or 
continuing education programs specific 
to bum intensive care services that shall 
be provided to unit stafF; and 

(10) copies of written policies and proce- 
dures for the operation of the bum 
intensive care unit that shall be in effect 
at the time the unit becomes operation- 
al, for at least the follo\».'ing: 

(A) arrangements for treatment of a pa- 
tient u'hen patient load exceeds opti- 
mal operational capacity; 

(B) patient admission and discharge poli- 
cies that are developed with input 
from the medical staff and the nursing 
service; 

(O infection control and pre\'ention. 
including handling of contaminated 
items, decontamination, transportation 
of patients outside of the unit, house- 
keeping and cleaning schedule, solid 
and liquid waste systems, staff and 
visitor traffic control, and aseptic 



iD) 



isolation; 
the inclusion 



of the unit 



the 



facility's extemal and internal disaster 
plans; 

(E) performance of special procedures; 
and 

(F) acquisition and storage of homograft 
and heterograft skin. 

(c) The applicant shall provide documentation, 
including a detailed floor plan of the proposed unit 
drawn to scale, to demonstrate that the proposed 
unit shall: 

( 1 ) be organized as a physically and func- 
tionally distinct entity with controlled 
access; 

(2) provide an effective means of isolation 
for patients suffering from communica- 
ble or infectious disease, for patients 



14) 



requiring protective isolation, and for 

disoriented or emotionally disturbed 

patients who require the services of the 

unit until placement elsewhere becomes 

possible; 

provide a means for obsen.'ation by unit 

staff of all patients from at least one 

vantage point; and 

contain no fewer than 6 licensed acute 

care beds. 



Statuton Authority- G.S. 131 £-177(1). 

.3403 REQUIRED PERFORMANCE 
STANDARDS 

(a) An applicant proposing to develop a new 
bum intensive care unit or to add a bed to an 
existing or approved bum intensive care unit shall 
demonstrate that: 

(1) the existing bum intensive care units in 
the state had an overall average occu- 
pancy rate of at least 80 percent for the 
last year, which shall be calculated by 
dividing the total number of bed days 
utilized in the last year by severely 
burned patients in all facilities in the 
state that have burn intensive care units, 
by the total number of bum intensive 
care unit beds in all facilities |n the 
state that have bum intensive care units 
multiplied by 365 days ; 

(2) the average occupancy rate of the 
applicant's existing unit for the fast year 
was at least 70% in units with 20 or 
more beds. 65% in units with 10 to 19 
beds, and 60% in units with i to 9 
beds; 

the applicant's unit shall be utilized at 
an annual occupancy rate of at least 
70% in units with 20 or more beds. 
65% in units with fO to J_9 beds, and 
60% in units with i to 9 beds, no later 
than 2 years following completion of 
the proposed project; and 
each existing or approved bum inten- 
sive care unit shall be projected to be 
utilized at an annual occupancy rate of 
at least 70% in units with 20 or more 
beds, 65% in units with 10 to 19 beds. 



£3] 



14] 



and 60% in units with i to 9 beds, no 
later than 2 years following completion 
of the applicant's proposed project. 
(h) The calculation of occupancy rates in this 

Rule shall be based only on se\'erely bumed 

patients. 



1062 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



(c) The applicant shall document all assumptions 
and data supporting the methodology used for all 
occupancy rates projected in this Rule. 

Statutory Authority G.S. 131E-177(1). 

.3404 REQUIRED SUPPORT SERVICES 

(a) An applicant proposing to develop a new 
bum intensive care unit or to add a bed to an 
existing or approved bum intensive care unit shall 
demonstrate that the following services, equipment 
and supplies shall be available to the bum 
intensive care unit 24 hours per day, 7 days per 
week: 

(1) monitoring devices which allow nurses 
at a nursing station to monitor patients 
around-the-clock; 

(2) ventilator capability at each bed in the 
unit: 

(3) a tub, tank or table for the cleaning of 
bum wounds located in an area of the 
unit separate from the general patient 
care area; 



141 



£5} 
16} 

m 



18} 
£9} 
(10) 

an 



(12) 
(13) 
(14) 
(15) 
(16) 
(17) 



temperature control equipment or capa- 
bility which allows for independent 
temperature control for each patient 
area; 

renal dialysis; 
an operating room; 

a clinical laboratory which is capable of 
performing tests and reporting the 
results on a timely basis, including 
blood chemistries, blood gas analyses, 
Ph levels, electrolyte determinations, 
and serum and urine osmolalities; 
microbiology services; 
blood bank services; 
diagnostic radiologic services; 
a direct intercommunication/alarm 
system between the nurses' station and 
the patient's bedside, with connections 
to treatment, work, lounge, or other 
areas from which additional personnel 
would be summoned; 
oxygen and compressed air and the 
means of administration; 
mechanical ventilatory assistance equip- 
ment; 

cardiac defibrillator with synchroniza- 
tion capability; 

respiratory and cardiac monitoring 
equipment; 

thoracentesis and closed thoracostomy 
sets; 
tracheostomy sets; 



(18) tourniquets; 

(19) vascular cutdown sets: 

(20) infusion pumps; 

(21) laryngoscopes and endotracheal tubes; 

(22) tracheobronchial and gastric suction 
equipment; 

(23) portable x-ray equipment; and 

(24) a patient weighing device for bed pa- 
tients. 

(b) An applicant proposing to develop a new 
bum intensive care unit or to add a bed to an 
existing or approved bum intensive care unit shall 
also demonstrate that the following services shall 
be available: 

(1) aftercare services to bum unit patients 
for post hospitalization including social 
services, vocational counseling and 
physical rehabilitation; and 

(2) a community outreach and prevention 
education program, which shall include. 
but not be limited to, coordination with 
emergency medical service authorities 
in training in the assessment, care, 
triage and transfer of severely burned 
patients. 

Statutory Authority G.S 131E-177(1). 

.3405 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) An applicant proposing to develop a new 
bum intensive care unit or to add a bed to an 
existing or approved burn intensive care unit shall 
demonstrate that the following staff shall be avail- 
able to provide the proposed services: 

(1) a designated physician in charge of the 
unit with board certification in general 
or plastic surgery and at least one year 
of experience m a burn unit; 

(2) in-house physician coverage by either a 
stafl^ physician or a member of the 
house staff assigned to the unit 24 
hours per day, 7 days per week; 

(3) a registered nurse administratively 
responsible for the nursing service in 
the unit who has at least two years of 
intensive care or equivalent experience 
and experience working with bum 
patients; 

(4) a bum specialist 24 hours per day, 7 
days per week; 

(5) a bum care technician 24 hours per 
day, 7 days per week: 

(6) designated support staff available to the 
unit, including: 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1063 



PROPOSED RULES 



lA) 


anesthetist. 


im 


chaplain. 


IC) 


dietician. 


ID] 


inhalation therapist. 


lEl 


microbiologist. 


ill 


occupational therapist. 


IG} 


pharmacist. 


im 


physical therapist, and 


m 


social worker; 


m 


other non-surgical support services staff 




available for consultation, including: 


(A) 


anesthesiology. 


mi 


cardiology. 


iC) 


gastroenterology. 


£D1 


hematology. 


IE} 


infectious disease. 


£F} 


internal medicine. 


mi 


nephrology. 


(HI 


neurology. 


m 


nutrition. 


m 


ophthalmology. 


IK) 


pathology. 


ID 


pediatrics. 


IMl 


psychiatry. 


m 


pulmonap,'. 


iOi 


radiology, and 


IP) 


special education; and 


18} 


surgical support specialists available for 




consultation, including: 


lA) 


cardiothoracic. 


IB) 


neurologic. 


IC) 


OB-GYN, 


ID} 


ophthalmic. 


IE) 


oral and maxillofacial. 


IF) 


orthopaedic. 


IG) 


otorhinolaryngologic. 


I£Q 


pediatric. 


m 


plastic (if not the director of the bum 




unit). 


ID 


urologic. and 


IK) 


vascular. 


lb) An 


applicant proposing to develop a new 


bum intensive care unit or to add a bed to an 


existins or 


approved burn intensive care unit shall 


demonstrate that an organized staff education and 


training program shall be provided which is inte- 


gral to the 


bum intensive care service unit and 


which ensures improvements in technique and the 


proper training of new personnel. 



Statutory Authorin' G.S. 131E-177(lj. 

.3406 DATA REPORTING REQUIREMENTS 

The applicant shall provide, upon the request of 
the Division of Facility Services, the following 



types of data and information, in accordance with 
data format and reporting requirements formulated 
by the Division of Facility Services: 

( 1 ) demographic data on patients treated: 

(2) financial data; and 

(3) clinical data. 

Statutory Authorm' G.S. 1 31 E- 177(1). 

.3407 ACCESSIBILITY' 

(a) The applicant shall provide documentation 
describing the mechanism that shall be used to 
ensure that the projected number of medically 
underserved shall be served in the unit. 

(h) The applicant shall provide a copy of the 
written admissions policies identifying any prepay- 
ment or deposit requirements for the facility and 
stating the admissions requirements for the follow- 
ing payor categories: 



m 

12} 

£41 
£51 
£61 



Medicare; 
Medicaid; 
Blue Cross and Blue Shield; 



indigent 



m 



Commercial Insurance; 

State Employees Health Plan; 

Self-Pay (includes self-pay. 

and charity' care); and 

Other as identified by the applicant. 

(c) The applicant shall provide a written descrip- 
tion of the billing procedures, including the credit 
collection policies, that shall be utilized by the 
facility. 

(d) The applicant shall document that the health 
care community in the "bum intensive care" 
service area, including the Departments of Social 
Services and Health, have been invited to comment 
on the proposed project, particularly with regard to 
the facility's referral mechanisms and admissions 
policies for the medically underserved. 

Statutory Authorit}- G. S 131 £-177(1). 

SECTION .3500 - CRITERIA AND STAN- 
DARDS FOR ONCOLOGY TREATMENT 
CENTERS 

.3501 DEFINITIONS 

The following definitions shall apply to all rules 
in this Section: 

(1) "Major medical equipment" is defined in 
G.S. 131E-176(14f). 

(2) "Medical equipment" means equipment 
used by the oncology treatment center to 
diagnose or treat disease or injury m 
patients, including major medical equip- 
ment. 



1064 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



£4} 
£5} 



16} 



18} 



£9} 



(10) 



LllJ 



"Medical oncologist" is a physician with 
a special interest in and competence in 
managing patients with cancer. 
"Medicine-Oncology" means a clinical 
medical specialty with a specific involve- 
ment with the treatment of tumors. 
"Oncology diagnostic services" means 
those services which include, but are not 
limited to. procedures using diagnostic 
radiology and imaging techniques, clini- 
cal and pathological laboratory tests, or 
physical examination to obtain informa- 
tion from which a diagnosis is 
established. 
"Oncology 



evaluation services" means 
the compilation of all diagnostic test 
results and consultation reports for the 
development of a patient specific 
treatment plan to provide curative or 
palliative cancer treatment. 
"Oncology treatment center" is defined in 
G.S. 131E-176(18a). 
"Oncology treatment center service area" 
means the geographic area defined by the 
applicant from which patients will 
originate who will receive the health 
services proposed. 

"Oncology treatment services" means 
curative or palliative services provided to 
cancer patients which involve the use of 
radiation therapy, chemotherapy or other 
treatment techniques. 
"Radiation oncologist" means a medical 
physician with a special interest, training 
and competence in managing patients 
with cancer who is certified by the 
American Board of Radiology or its 
equivalent. 

" Radiology-Oncology " means a clinical 
medical specialty involving the treatment 
of tumors, particularly as they relate to 
treatment with ionizing radiation. 



provide similar services in the proposed 
oncology treatment center's service 
area; 

(2) a list of the medical/surgical specialties 
in the existing oncology treatment 
centers and other health service facili- 
ties which provide similar services in 
the proposed oncology treatment center 
service area, such as Radiation-Oncolo- 
gy. Medicine-Oncology, and surgical 
specialties; 

(3) a list of the medical equipment that is 
proposed to be acquired; 

(4) documentation verifying the actual cost 
or market value of each item of medical 
equipment, whichever is greater; 

(5) documentation that the proposed servic- 
es shall result in an integrated multi- 
disciplinary effort to diagnose and treat 
patients' clinical and psychosocial 
needs; 

(6) a list of all oncology diagnostic, oncol- 
ogy evaluation, and oncology treatment 
services that shall be available, and 
documentation demonstrating the means 
by which these services shall be provid- 
edi 

(7) documentation that coordination and 
referral agreements exist with a hospi- 
tal, referring physicians, and surgical 
and medical specialists and sub- 
specialists; and 

(8) documentation that the services shall be 
offered in a physical environment that 
conforms to the requirements of feder- 
al, state, and local regulatory bodies. 

(c) An a pplicant proposing to acquire radiation 
therapy equipment shall document compliance with 
10 NCAC 3R .1900, Criteria and Standards for 
Radiation Therapy Equipment. 

Statutory Authority G.S. 131-177(1). 



Statutory Authority G.S 131-177(1). 

.3502 EVTORMATION REQUIRED OF 
APPLICANT 

(a) An a pplicant proposing to develop a new 
oncology treatment center shall use the Acute Care 
Facility/Medical Equipment application form. 

(h) An applicant shall also submit the following 
additional information: 

(1) documentation of the number of exist- 
ing oncology treatment centers and 
other health service facilities which 



.3503 NEED FOR SERVICES 

An applicant proposing to develop an oncology 
treatment center shall provide the following 
information: 

(1) the number of patients that are projected 
to use the service, classified by diagnosis 
and by county of residence; 

(2) documentation of the maximum number 
of procedures that the equipment in the 
facility js capable of performing; 

(3) quarterly projected utilization of the 
applicant's new equipment for each of the 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1065 



PROPOSED RULES 



first three years after the completion of 
the project; 

(4) documentation of the effect the new 
oncology treatment center may have on 
existing oncology treatment centers and 
other health service facilities which 
provide similar services in the proposed 
oncology treatment center service area; 
and 

(5) all the assumptions and data supporting 
the methodology used for the projections. 

Statutory Authority G.S. 131E-177(1). 

.3504 REQUIRED SUPPORT SERVICES 

(a) An applicant proposing to develop an 
oncology treatment center shall document that the 
following services will be available to the center: 
(1) medical oncology services; 
radiation oncology services; 
diagnostic radiology services; 
nuclear medicine services; 



12} 
13} 
{4} 
15} 
£6} 
£7} 
18} 
£9} 
(10) 



hospice and home health services; 
psychology and social services; 
pharmaceutical services; 
pathology services; 
transportation services; and 
tumor registry services. 

(b) An applicant proposing to develop an 
oncology treatment center shall specify whether 
any services other than those listed in Paragraph 
(a) of this Rule will be available to the center and 
shall list those additional services. 

(c) An applicant proposing to develop an 
oncology treatment center shall list the types of 
surgical specialties which will be available to the 
center- 
ed) An applicant proposing to develop an 

oncology treatment center for the provision of 
medical-oncology services shall document that the 
following services will be available in the center: 

(1) pharmaceutical services; and 

(2) pathology services. 

(e) An applicant proposing to develop an 
oncology treatment center for the provision of 
radiation-oncology services shall document that 
diagnostic radiology services will be available in 
the center. 

Statutory Authority G.S. 121-177(1). 

.3505 REQUIRED STAFFING AND STAFF 
TRAINING 

An applicant proposing to establish a new 
oncology treatment center shall provide the 



following information: 
(1) the medical specialties and board 
certification status of each of physician 
who will provide services in the proposed 
center. An applicant shall also provide 
documentation of at least the following 
types of physicians: 
(a) if proposing radiation-therapy services. 

a radiation oncologist; 
fb) if proposing radiation-therapy services, 
access to a medical oncologist; 
(T) a description of the special training and 
specialty certification which will be 
required of all registered nurses who will 
be employed by the center; 

(3) documentation to show that the 
appropriate types and numbers of stafF. 
particularly qualified medical 
technologists and medial staff, shall be 
available to support the services; and 

(4) documentation to demonstrate that a 
formal training program exists to ensure 
the continued proficiency of the 
professional and technical staff". 

Statutory Authority G.S. 131-177(1). 

.3506 DATA REPORTING REQUIREMENTS 

The applicant shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information, in 
accordance with data format and reporting 
requirements formulated by tlie Division of 
Facility Services: 

(1) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S 131-177(1). 

.3507 ACCESSIBILITY 

(a) The applicant shall provide documentation 
describing the mechanism that will be used to 
insure that the projected number of medically 
underserved will be served in tlie facility. 

(b) The applicant shall provide written 
admissions policies identifying any prepayment or 
deposit requirements for the facility and stating the 
admission requirements for patients in each of the 
following payor categories: 

(1) Medicare; 

(2) Medicaid; 

£3} Blue Cross and Blue Shield; 

(4) Commercial Insurance; 

(5) State Employees Health Plan; 



1066 



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PROPOSED RULES 



(6) Self-Pay (includes self-pay. Indigent 
and charity care); and 

(7) Other as identified by the applicant. 

(c) The applicant shall provide a written 
description of the billing procedures, including the 
credit and collection policies that will be utilized 
by the facility. 

(d) The applicant shall document that the health 
care community in the service area, including the 
Departments of Social Services and Health, have 
been invited to comment on the proposed project, 
particularly with regard to the facility's referral 
mechanisms and admissions policies for the 
medically underserved. 

Statutory Authority G.S. 131-177(1). 

SECTION ,3600 - CRITERIA AND 
STANDARDS FOR GAMMA KNIFE 

.3601 DEFINITIONS 

The following definitions shall apply to aU rules 
in this Section: 
(1) "Approved gamma knife" means a 
gamma knife which was not operational 
prior to the beginning of the review 
period but which had been issued a 
certificate of need or had been acquired 
prior to March 18, 1993 in accordance 
with G.S. 131E-175. et. al. 
"Existing gamma knife" means a gamma 
knife in operation prior to the beginning 
of the review period. 
"Gamma knife" is defined in G.S. 13 lE- 
176(7c). 

"Gamma knife procedure" means a 
radiation dosage delivered in one 
treatment session. 
"Gamma knife service area" 



12} 

£3} 
(41 

15} 



means the 

geographic area defined by the applicant. 



Statutory Authority G.S. 131E-177(1). 

.3602 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing the acquisition of a 
gamma knife shall use the Acute Care 
Facility/Medical Equipment application form. 

(b) The applicant shall also provide the 
following additional information: 

(1) copies of written policies that establish 
the gamma knife as a regional resource 
having no administrative, clinical or 
charge requirements which would 
impede physician referrals of patients 



for whom gamma knife procedures 
would be appropriate; 

(2) documentation that the following 
diagnostic modalities have been 
operational in the facility in which the 
gamma knife will be used for at least 
12 months prior to the submittal of the 
application: 

(A) magnetic resonance imaging (MRI); 

(B) angiography, including digital; 

(C) neuro angiography and CT services; 
and 

(D) linear accelerator; 

(3) if the proposed gamma knife will be 
used for clinical use or for clinical 
trials, documentation that all 
equipment. supplies and 
pharmaceuticals proposed for the 
service have been certified for clinical 
use by the U.S. Food and Drug 
Administration or that the gamma knife 
shall be operated under an institutional 
review board whose membership is 
consistent with U.S. Department of 
Health and Human Service regulations; 

(4) if the proposed gamma knife will be 
used for experimental or research 
activities, documentation of the sources 
of funds to be used to finance the 
capital cost and operational costs of the 
gamma knife; 

(5) documentation of tlie projected number 
of procedures, by type, to be 
performed In each of the first 12 
calendar quarters following completion 
of the proposed project, including the 
methodology and assumptions used for 
these projections; 

(6) documentation of the type and estimated 
number of procedures performed in the 
facility that the gamma knife will 
replace or complement; 

£7} evidence that protocols will be 
established to assure that all clinical 
gamma knife procedures performed are 
medically necessary and that alternative 
treatment modalities have been 
considered; and 

(8) evidence of cooperative agreements 
with facilities and appropriate 
individuals to assure efficient equipment 
utilization and availability of the gamma 
knife, including: 
(A) letters from qualified physicians 
indicating their intent to use the 



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1067 



PROPOSED RULES 



gamma knife proposed by the 
applicant and to comply with all 
relevant gamma knife criteria and 
guidelines; and 
(B) the provisions that have been 
established to accommodate referrals 
from other facilities in the gamma 
knife service area. 

Statutory Authority G.S. 121E-177(1). 

.3603 REQUIRED PERFORMANCE 
STANDARDS 

An applicant proposing to acquire a gamma knife 
shall: 

demonstrate that all existing gamma 



m 



121 



O) 



141 



knives in the applicant's gamma knife 
service area performed at least 408 
procedures during the twelve month 
period immediately preceding submittal 
of the application; 

project an annual utilization of at least 
326 procedures per year by the end of 
the third year of operation and provide 
all assumptions and data supporting the 
methodology used for the projections; 
for the projections provided in response 
to Item (2) of this Rule, calculate the 
number of procedures projected to be 
performed for clinical purposes and the 
number of procedures projected to be 
performed for research purposes; and 
demonstrate that all of the existing and 
approved gamma knives in the applicant's 
gamma knife service area shall be 
performing at least 326 gamma knife 
procedures per year in the third year of 
operation of the new gamma knife, and 
provide all assumptions and data 
supporting the methodology used for the 
projections. 



Statutory Authority G.S. 131E-177(1). 

.3604 REQUIRED SUPPORT SERVICES 

(a) An applicant proposing to acquire a gamma 
knife shall provide documentation, such as formal 
consultation agreements or letters of commitment, 
that physicians certified in the following specialty 
areas shall be available for consultation: 

(1) neurological surgery. 

£21 radiation oncology. 

£31 medical physicist. 

£41 diagnostic radiology. 

(5) anesthesiology. 



(6) otolaryngology, and 

(7) neurology. 

£bl An applicant proposing to acquire a gamma 
knife shall demonstrate how medical emergencies 
within the gamma knife unit will be managed in 
conftirmity with accepted medical practice. 

Statutory Authority G.S. 131E-177(1). 

.3605 REQUIRED STAFF AND STAFF 
TRAINING 

(a) The applicant shall demonstrate that the 
following persons shall be available to provide the 
proposed services: 

(1) a neurological surgeon who is familiar 
with the principles of craniospinal 
irradiation and has expertise in 
conventional stereotactic surgery. 
microsurgery, and selection of target 
volumes defined by neuroimaging; 

(2) a radiation oncologist who is familiar 
with the principles of stereotactic 
imaging and has experience with 
precise single fraction irradiation of 
small target volumes; 
qualified radiophysicist with 



m 



documented training in radiosurgery; 

and 
£41 qualified gamma knife nurse with 

documented training in radiosurgery. 
(h) The applicant shall provide documentation 
that each staff member as identified in Paragraph 
(a) of this Rule who will be initiating gamma knife 
procedures shall have specific, documented 
training in radiosurgery prior to the operation of 
the gamma knife, including attendance at specific 
courses or symposia and a site visit at a center that 
is currently performing radiosurgery. The 
documentation shall confirm that each team 
member has had education that includes: 

(1) analysis of prior results. 

(2) patient selection. 

(3) stereotactic head frame application. 
£41 stereotactic neurodiagnostic imaging 

using all pertinent modalities, 
target selection. 
dose determination. 



£51 
161 

m 

£81 
£91 



dose prescription. 

treatment delivery, and 

instructions regarding radiation effects 

and protection. 

(c) The applicant shall submit documentation 

which demonstrates the availability of inservice 

training or continuing education programs for its 

staff" specific to the provision of gamma knife 



1068 



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PROPOSED RULES 



services. 

(d) The applicant shall submit documentation 
which demonstrates that at least one staff member 
who is certified in CPR and basic life support shall 
be present in the facility at all times. 

Statutory Authority G.S. 131E-]77(1). 

.3606 ACCESSIBILITY 

(a) An applicant that proposes to acquire a 
gamma knife shall provide documentation 
describing the mechanism that will be used to 
assure that the projected number of medically 
underserved will be served by the a pplicant. 

(b) The a pplicant shall provide written 
admissions policies identifying any prepayment or 
deposit requirements which state the admissions 
requirements for patients in each of the following 
payor categories: 



m 

121 
£3} 
^ (41 
15} 
£6] 

m 



Medicare: 

Medicaid; 

Blue Cross and Blue Shield: 

Commercial Insurance: 

State Employees Health Plan: 

Self-Pay (includes self-pay. 



indigent 



and charity care): and 

Other as identified by the applicant. 
The applicant shall provide a written 
description of the billing procedures, including the 
credit and collection policies that will be utilized 
by the applicant. 

(d) The applicant shall document that the health 
care community in the gamma knife service area, 
including the Departments of Social Services and 
Health, have been invited to comment on the 
proposed project, particularly with regard to the 
applicant's referral mechanisms and admissions 
policies for the medically underserved. 

Statutory Authority G.S. 131 E-] 77(1). 

.3607 DATA REPORTING REQUIREMENTS 

The applicant shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information, in 
accordance with data format and reporting 
requirements formulated by the Division of 
Facility Services: 

(1) demographic data on patients treated: 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S 131E-177(1). 

SECTION .3700 - CRITERIA AND 



STANDARDS FOR POSITRON EMISSION 
TOMOGRAPHY SCANNER 

.3701 DEFINITIONS 

The following definitions shall apply to aH rules 
in this Section: 

(1) "Approved positron emission tomography 
(PET) scanner" means a PET scanner 
which was not operational prior to the 
beginning of the review period but which 
had been issued a certificate of need or 
had been acquired prior to March 18, 
1993 in accordance with G.S. 131E-175, 

(2) "Cyclotron" means an apparatus for 
accelerating protons or neutrons to high 
energies by means of a constant magnet 
and an oscillating electric field. 

(3) "Existing PET scanner" means a PET 
scanner in operation prior to the 
beginning of the review period. 

(4) "PET procedure" means a single discrete 
study of one patient involving one or 
more PET scans. 

(5) "PET scan" means an image-scanning 
sequence derived from a single 
administration of a PET 
radiopharmaceutical , equated with a 
single injection of the tracer. One or 
more PET scans comprise a PET 
procedure. 

(6) "PET scanner service area" means a 
geographic area defined by the applicant 
from which patients to be admitted to the 
service will originate. 

(7) "Positron emission tomographic scanner" 
(PET) is defined in G.S. 131E-176( 19a). 

(8) "Radioisotope" means a radiochemical 
which directly traces biological processes 
when introduced into the body. 

Statutory Authority G.S. 131E-177(1). 

.3702 EVFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing to acquire a PET 
scanner shall use the Acute Care Facility/Medical 
Equipment application form. 

£b] The applicant shall also provide the 
following additional information: 

(1) The projected number of scans, the 
projected number of procedures, and 
the projected number of patients for 
each of the first 12 calendar quarters 
following completion of the proposed 



8:12 



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September 15, 1993 



1069 



PROPOSED RULES 






IE] 

IB 

IG] 



project. Projections shall be listed by 
clinical area (i .e. oncology, 
cardiology). The applicant shall include 
all methodologies and assumptions 
used. 

(2) Documentation that the applicant has 
provided all of the following services 
continuously throughout the twelve 
months immediately prior to the date on 
which the application js filed: 

nuclear medicine imaging services: 
single photon emission computed 
tomography (including brain, bone, 
liver, gallium and thallium stress): 
magnetic resonance imaging scans; 
computerized tomography scans: 
cardiac angiography: 
cardiac ultrasound; and 
neuroangiography. 

(3) If the PET scanner will be used for 
experimental or research purposes, the 
applicant shall document how capital 
costs and service operations will be 
funded. 

(4) If the PET scanner will be used for 
clinical purposes, the applicant shall 
specify the type and estimated number 
of other diagnostic procedures that the 
PET scanner will replace or 
complement in the facility. 

(5) If the PET scanner will be used for 
clinical purposes, the applicant shall 
develop and submit policies which: 

(A) establish the clinical PET unit, and 
any accompanying equipment used m 
the manufacture of positron-emitting 
radioisotopes, as a regional resource 
that will have no administrative, 
clinical or charge requirements that 
would impede physician referrals of 
patients for whom PET testing would 
be appropriate: 

(B) prescribe that services or scheduled 
testing will be available a minimum of 
12 hours per day, six days a week; 
and 

(O implement a referral system which 
shall include a feedback mechanism of 
providing patient information to the 
referring physician and facility. 

(6) If the PET scanner will be used for 
clinical purposes, the applicant shall 
identify those protocols that will be 
established to assure that all clinical 
PET procedures performed are 



medically necessary and cannot be 
performed using other, less expensive, 
esfablished modalities. 



Statutory Authority G.S. 131E-177(1). 

.3703 REQUIRED PERFORMANCE 
STANDARDS 

An applicant proposing to acquire a PET scanner 
shall demonstrate that: 

( 1 ) all equipment, supplies and 
pharmaceuticals proposed for the service 
have been certified for use by the U.S. 
Food and Drug Administration or will be 
used under an institutional review board 
whose membership is consistent with 
U.S. Department of Health and Human 
Services regulations: 

(2) each PET scanner proposed for clinical 
use shall be utilized at an annual rate of 
at least 1.524 clinical procedures within 
its proposed PET scanner service area by 
the end of the third year following 
completion of the project. The applicant 
shall describe all assumptions and 
methodologies used in making these 
projections; 

(3) if the PET scanner will be used for 
clinical purposes, all existing clinical 
PET scanners in the applicant's PET 
scanner service area performed 1.524 
clinical procedures durin g the twelve 
months immediately prior to the date on 
which the application was filed: 

(4) if the PET scanner will be used for 
clinical purposes, all existing and 
approved clinical PET scanners m the 
applicant's PET scanner service area will 
perform at least 1 .524 clinical procedures 
during the third year following 
completion of the project. All 
assumptions and methodologies used in 
making these projections shall be 
described in the application; and 
each PET scanner and cyclotron shall be 
operated in a physical environment that 
conforms to federal standards, 
manufacturers specifications. and 
licensing requirements. The following 
shall be addressed: 



15} 



ia] 



M 



quality control measures and assurance 
of radioisotope production of generator 
or cyclotron-produced agents: 
quality control measures and assurance 
of PET tomograph and associated 



1070 



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September 15, 1993 



PROPOSED RULES 



instrumentation: 

(c) radiation protection and shielding; 

(d) radioactive emission to the 
environment: and 

(e) radioactive waste disposal. 

Statutory Authority G.S. 131E-177(1). 

.3704 REQUIRED SUPPORT SERVICES 

(a) An applicant proposing to acquire a PET 
scanner shall document how medical emergencies 
within the PET scanner unit will be managed m 
conformity with accepted medical practice. 

(b) An applicant proposing to acquire a PET 
scanner shall document that radioisotopes shall be 
acquired from one or more of the following 
sources and shall identify the sources which will 
be utilized by the applicant: 

(1) an off-site medical cyclotron and 
radioisotope production facility that is 
located within two hours transport time 
to the facility: 

(2) an on-site rubidium-82 generator: or 

(3) an on-site medical cyclotron for radio 
nuclide production and a chemistry unit 
for labeling radioisotopes. 

(c) An applicant proposing to acquire an on-site 
cyclotron for radioisotope production shall 
document that these agents are not available or 
cannot be obtained in an economically cost 
efiFective manner from an ofF-site cyclotron located 
within 2 hours total transport time from the 
applicant's facility. 

(d) An applicant proposing to acquire a PET 
scanner shall document that a clinical oversight 
committee will be created before the proposed 
PET scanner is placed rn service and that the 
committee shall: 

(1) develop screening criteria for 
appropriate PET scanner utilization: 

(2) review clinical protocols: 

(3) review appropriateness and quality of 
clinical procedures: 

(4) develop educational programs: and 

(5) oversee the data collection and 
evaluation activities of the PET 
scanning service. 

Statutory Authority G.S. 131 £-177(1). 

.3705 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) An applicant proposing to acquire to acquire 
a PET scanner shall document that the scanner will 
be staffed by the following personnel: 



(1) One or more full-time nuclear medicme 
imaging physicians who: 

(A) are licensed by the State to handle 
medical radioisotopes: 

(B) have specialized in the acquisition and 
interpretation of nuclear images, 
including tomographic studies, for at 
least one year: 

(C) have acquired knowledge about PET 
through experience or postdoctoral 
education: and 

(D) have had practical training with an 
operational PET scanner. 

(2) Engineering and physics personnel with 
training and experience in the operation 
and maintenance of PET scanning 
equipment: 

£3} Radiation safety personnel with training 
and experience in the handling of short- 
lived positron emitting nuclides: and 
(4) Certified nuclear medicine technologists 
with training and experience in positron 
emission computed tomographic nuclear 
medicine imaging procedures, 
(b) An applicant proposing to acquire a 
cyclotron shall document that the cyclotron shall 
be stafFed by radiochemists or radiopharmacists 
who: 

(1) have at least one year of training and 
experience in the synthesis of short- 
lived positron emitting radioisotopes: 



and 



£2} 



have at least one year of training and 
experience in the testing of chemical, 
radiochemical, and radionuclidic purity 
of PET radiopharmaceutical synthesis. 

(c) An applicant proposing to acquire a PET 
scanner, a cyclotron, or both, shall document that 
the personnel described in Paragraphs (a) and fb) 
of this Rule shall be available at all times that the 
scanner and cyclotron are operating. 

(d) An applicant proposing to acquire a PET 
scanner shall document that it shall develop and 
oflFer a program of continuing stafF education 
which will insure the proper training of new 
personnel and the maintenance of staff competence 
as clinical PET applications, techniques and 
technology continue to develop and evolve. 

Statutory Authority G.S 131 £-177(1). 

.3706 DATA REPORTEMG REQUIREMENTS 

An applicant shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information jn 



8:12 



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September 15, 1993 1071 



PROPOSED RULES 



accordance with 
requirements 



data format 



and reporting 

by the Division of 



formulated 
Facility Services: 

( 1) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S. 131 £-177(1). 

.3707 ACCESSIBILITY 

(a) An applicant shall provide documentation 
describing the mechanism that will be used to 
ensure that the projected number of medically 
underserved will be served in the facility. 

(b) An applicant shall provide written 
admissions policies identifying any prepayment or 
deposit requirements and stating the admission 
requirements for patients in each of the following 
payor categories: 

(1) Medicare; 
Medicaid; 

Blue Cross and Blue Shield; 
Commercial Insurance; 



£3} 
£41 

£61 

ill 



State Employees Health Plan; 

Self- Pay (includes self-pay, indigent 

and charity care); and 

Other as identified by the applicant. 
An applicant shall provide a written 
description of the billing procedures, including the 
credit and collection policies that will be utilized 
by the applicant- 
id) An applicant shall document that the health 
care community in the PET scanner service area, 
including the Departments of Social Services and 
Health, have been invited to comment on the 
proposed project, particularly with regard to the 
applicant's referral mechanisms and admissions 
policies for the medically underserved. 

Statutory Authority G.S. 131E-177(1). 

SECTION .3800 - CRITERIA AND 

STANDARDS FOR BONE MARROW 

TRANSPLANTATION SERVICES 

.3801 DEFINITIONS 

The following definitions shall apply to al] rules 
in this Section: 

(1) "Allogeneic bone marrow transplantation 
services" means the procedure by which 
the bone marrow of a person other than 
the patient is infused after treating the 
patient for disease. 

(2) "Approved bone marrow transplantation 
service" means an allogeneic or an autolo- 



gous bone marrow transplantation service 
which was not operational prior to the 
beginning of the review period but which 
had been issued a certificate of need or 
had been developed and offered prior to 
March 18, 1993 in accordance with G.S. 
131E-175, et. al. 

(3) "Autologous bone manow transplantation 
services" means the process of reinfusing 
the patient's own bone marrow after 
treating the patient for disease. 

(4) "Bone marrow transplantation service 
area" means a geographic area defined by 
the applicant from which patients to be 
admitted to the service will originate. 

(5) "Bone marrow transplantation services" 
is defined in G.S. I31E-I76(2a). 

(6) "Cryopreservation" means the process of 
preserving tissue by freezing at very low 
temperatures. 

(7) "Existing bone marrow transplantation 
service" means an allogeneic or an autol- 
ogous bone marrow transplantation ser- 
vice in operation prior to the beginning 
of the review period. 

Statutory Authority G.S 1 31 E- 177(1). 

.3802 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing new or expanded 
autologous or allogeneic bone marrow transplanta- 
tion services shall use the Acute Care 
Facility/Medical Equipment application form. 

(b) An applicant proposing new or expanded 
autologous or allogeneic bone marrow 
transplantation services shall also provide the 
following additional information: 

(1) the projected number of autologous and 
allogeneic transplant patients by disease 
type (e.g. Hodgkin's lymphoma Stage 
III) to be performed m each of the first 
12 calendar quarters following 
completion of the proposed project, 
including the methodology and 
assumptions used for these projections; 
and 

(2) a copy of the a pplicant's proposed 
policy and guidelines for participation 
in peer- reviewed clinical trials or 
research protocols. 

(c) An applicant that proposes new autologous 
or allogeneic bone marrow transplantation services 
shall provide documentation that the applicant will 
participate in approved clinical trials or research 



1072 



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September 15, 1993 



PROPOSED RULES 



protocols and also participate in a National Cancer 
Institute approved cooperative research group. 

(d) An applicant that proposes expanded 
autologous or allogeneic bone marrow 
transplantation services shall provide 
documentation that the applicant is participating in 
a pproved clinical trials or research protocols, and 
is participating in a National Cancer Institute 
a pproved cooperative research group. 

(e) An applicant that proposes to provide new or 
expanded autologous or allogeneic bone marrow 
transplantation services for clinical purposes shall: 

(1) provide documentation of existing 
referral networks and other referral 
sources for patients to be treated with 
bone marrow transplantation, and 

(2) identify the sources of reimbursement 
for the procedures and demonstrate the 
availability of these sources for 
treatment of the specific diseases 
proposed to be treated with bone 
marrow transplantation. 

(f) An a pplicant that proposes to provide new or 
expanded autologous or allogeneic bone marrow 
transplantation services for experimental or 
research purposes shall demonstrate how capital 
costs and service operations will be funded. 

Statutory Authority G.S. 131 £-177(1). 

.3803 REQUIRED PERFORMANCE 
STANDARDS 

(a) An applicant that proposes to provide new or 
expanded autologous or allogeneic bone marrow 
transplantation services shall demonstrate that: 

(1) all existing facilities within the 
applicant's bone marrow transplantation 
service area which have been offering 
bone marrow transplantation services 
for at least two years shall have 
performed at least 20 transplants during 
the most recent 12 month period; 

(2) all existing and approved facilities 
within the applicant's bone marrow 
transplantation service area will provide 
at least 20 transplants during the second 
year of operation following completion 
of the project; and 

(3) the projected utilization for the new or 
expanded bone marrow transplantation 
program shall perform at least 20 
transplants during the second year of 
operation following completion of the 
project. 

(b) An applicant that proposes to provide new or 



expanded autologous or allogeneic bone marrow 
transplantation services shall describe all of the 
assumptions and methodologies used to calculate 
the projections requested in Subparagraphs (a)(2) 
and (3) of this Rule. 

(c) An applicant that proposes the use of bone 
marrow transplantation services for clinical use 
shall demonstrate that all equipment, supplies and 
pharmaceuticals proposed for the service have 
been certified for clinical use by the U.S. Food 
and Drug Administration or will be operated under 
an institutional review board whose membership is 
consistent with U.S. Department of Health and 
Human Services regulations. 

Statutory Authority G.S 131 £-177(1). 

.3804 REQUIRED SUPPORT SERVICES 

(a) An applicant that proposes to provide new or 

expanded autologous or allogeneic bone marrow 

transplantation services shall demonstrate that the 

following will be available in the facility upon 

initiation of bone marrow transplantation services: 

(1) accommodations which offer 24 hour 

critical support and which are 

appropriate for patients whose immune 

systems are depressed from the effects 

of the treatment; 

air handling systems which are 
appropriate for patients whose immune 
systems are depressed from the effects 
of the treatment; 

if processing autologous bone marrow 
transplantation services, 

for the 



(21 

in 

141 
15} 



16} 

m 
mi 



(9) 

:io 



cryopreservation equipment 
storage of bone marrow; 
laboratory services which are available 
to the bone marrow transplant patient 
on a twenty-four hour basis; 
radiology services, including CT 
scanning and nuclear medicine, which 
are available to the bone marrow 
transplant patient on a twenty-four hour 
basis; 

total body radiotherapy for patients 
whose treatment protocols require total 
body irradiation; 

irradiated red cells, platelets and other 
blood products available on a twenty- 
four hour basis; 

access to blood bank services which are 
accredited by the American Association 
of Blood Banks; 

operating and recovery room resources; 
microbiology and virology laboratories; 



8:12 



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September 15, 1993 1073 



PROPOSED RULES 



(11) a multidisciplinary plan for providing 
rehabilitative services; 

(12) basic and clinical laboratory research; 

(13) an active, formal research program 
related to the proposed organ 
transplantation program; and 

(b) An applicant that proposes to provide new or 
expanded allogeneic bone marrow transplantation 
services shall also demonstrate that the following 
will be available in the facility upon initiation of 
allogeneic bone marrow transplantation services: 

(1) if proposing allogeneic bone marrow 
transplantation services. laboratory 
facilities for histocompatibility testing 
which are certified by the American 
Society for Histocompatibility and 
Immunogenetics; and 

(2) if proposing allogeneic bone marrow 
transplantation services, an established 
on-site program to promote organ 
donation. 

(c) A proposal to provide new or expanded bone 
marrow transplantation services shall provide 
evidence that, prior to the operation of the service, 
the applicant will develop a clinical oversight 
committee for bone marrow transplant services. 
The clinical oversight committee shall be 
responsible for the following activities: 

(1) developing screening criteria for 
appropriate bone marrow 
transplantation utilization; 

(2) reviewing clinical protocols; 

(3) reviewing appropriateness and quality 
of clinical procedures; 

(4) developing educational programs; and 

(5) overseeing the data collection, 
evaluation, and reporting activities of 
the bone marrow transplantation 
service. 

Statutory Authority G.S. 131E-177(1). 

.3805 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) An applicant shall demonstrate that it can 
meet each of the following staffing requirements: 

(1) a bone marrow transplant clinical 
coordinator; 

(2) a physician licensed to practice 
medicine in North Carolina who will be 
designated as the director of the 
program and who has documented 
experience within the past year in: 

(A) pretransplant evaluation; 

(B) bone marrow processing; 



(C) the provision of medical care services 
to hospitalized bone marrow 
transplant patients; and 

(D) post-transplant care; 

(3) availability of physician m the 
following specialties to the bone 
marrow transplantation program on a 
24 hour basis: 

(A) hematology or oncology; 

(B) gastroenterology; 

(C) nephrology; 

(D) infectious diseases; 

(E) pulmonary diseases; and 

(F) pediatrics (if pediatric patients will be 
treated) . 

(4) laboratory or nursing personnel staffed 
who are trained in the processing of 
bone marrow; 

(5) a state certified social worker with a 
master's degree in social work who is 
available for inpatient and outpatient 
ongoing support of both the patient and 
family; 

(6) a licensed practicing psychologist or 
licensed psychological associate who is 
available for inpatient and outpatient 
ongoing support of both the patient and 
family; 

(7) a board-certified or equivalently quali- 
fied psychiatrist who is available for 
inpatient and outpatient ongoing support 
of both the patient and family; 

(b) An applicant shall demonstrate that a pro- 
gram of staff education and training which is 
integral to the bone marrow transplantation service 
and which ensures improvements in technique and 
the proper training of new personnel will be 
provided. 

Statutory Authority G.S. 131 £-177(1). 

.3806 DATA REPORTING REQUIREMENTS 

(a) An applicant shall agree to report the results 
of aU transplants to the appropriate transplant 
registry (e.g. International Bone Marrow Trans- 
plant Registry IIBMTRI for allogeneic transplants 
and the North American Autologous Bone Marrow 
Transplant Registry [NAABMTR1 for autologous 
transplants). 

(b) An applicant shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and mformation, fn accor- 
dance with data format and reporting requirements 
formulated by the Division of Facility Services: 

(1) demographic data on patients treated; 



1074 



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September 15, 1993 



PROPOSED RULES 



(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S. 131E-177(1). 

,3807 ACCESSIBILITY 

(a) An applicant shall provide documentation 
describing the mechanism that will be used to 
insure that the projected number of medically 
underserved will be served in the facility. 

(b) An applicant shall provide written 
admissions policies identifying any prepayment or 
deposit requirements for the facility and stating the 
admission requirements for patients in each of the 
following payor categories : 

fl) Medicare; 

(2) Medicaid; 

(3) Blue Cross and Blue Shield; 

(4) Commercial Insurance; 

(5) State Employees Health Plan; 

(6) Self-Pay (includes self-pay, indigent 
and charity care); and 

(7) Other as identified by the applicant. 

(c) An applicant shall provide a written 
description of the billing procedures, including the 
credit and collection policies, that will be utilized 
by the facility. 

(d) An applicant shall document that the health 
care community in the bone marrow 
transplantation service area. including the 
Departments of Social Services and Health, have 
been invited to comment on the proposed project, 
particularly with regard to the facility's referral 
mechanisms and admissions policies for the 
medically underserved. 

Statutory Authority G.S. 131 £-177(1). 

SECTION ,3900 - CRITERIA AND 
STANDARDS FOR DIAGNOSTIC CENTERS 

,3901 PURPOSE AND SCOPE 

The rules set forth in this Section shall apply to 
applications for diagnostic centers for which 
specific criteria and standards have not otherwise 
been promulgated in 10 NCAC 3R. 

Statutory Authority G.S 131 £-177(1). 

,3902 DEFINITIONS 

The following definitions shall apply to all rules 
in this Section: 

(1) "Approved diagnostic center" means a 
diagnostic center that was not operational 
prior to the beginning of the review 



period but that had been issued a 
certificate of need or had been acquired 
prior to March 18. 1993 in accordance 
with G.S. 131E-175. et. al. 

(2) "Diagnostic center" is defined in G.S. 
131E-176(7a). 

(3) "Diagnostic center service area", unless 
otherwise defined by the State Medical 
Facilities Plan, means the geographic 
area, as defined by the applicant, for 
which the proposed diagnostic center will 
provide services. 

(4) "Diagnostic procedure" means a discrete 
diagnostic procedure with a distinct CPT 
code or ICD-9-CM procedure code 
performed on one patient during one visit 
to a diagnostic suite. 

(5) "Diagnostic suite" means a single room 
or group of rooms in a diagnostic center 
which is used for the purpose of 
conducting diagnostic procedures. 

(6) "Essential" means those items which are 
indispensable, the absence of which 
renders the equipment useless. 

£7} "Existing diagnostic center" means a 
diagnostic center in operation prior to the 
beginning of the review period. 

(8) "Freestanding diagnostic center" means a 
diagnostic center that is not operated as a 
part of another health service facility but 
rather as a discrete business entity. A 
freestanding diagnostic center may be 
owned by another health service facility 
and may be located on the campus of 
another health service facility. 

(9) "Medical diagnostic equipment" means a 
single piece of diagnostic equipment or a 
single component of a multi-component 
diagnostic system which costs ten 
thousand dollars ($10.000) or more, or 
whose fair market value is ten thousand 
dollars ($10.000) or more. 

(10) "Mobile medical diagnostic equipment" 
means medical diagnostic equipment and 
transporting equipment which is moved 
to provide services at two or more host 
facilities. 

(11) "Mobile diagnostic program" means the 
provision of diagnostic services using 
mobile medical diagnostic equipment and 
transporting equipment at two or more 
host facilities. 

(12) "Radiologic technologist or X-Ray techni- 
cian" means a person who, under the 
supervision of a physician radiologist. 



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1075 



PROPOSED RULES 



operates radiologic equipment and assists 
radiologists and other health profession- 
als, and whose competence has been 
tested and approved by the American 
Registry of Radiologic Technologists. 

Statutory Authority G.S. 131E-177(1). 

.3903 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing to establish a new 
diagnostic center or to expand an existing diagnos- 
tic center shall use the Acute Care Facility/Medical 
Equipment application form. 

(h) The applicant shall also provide the follow- 
ing additional information: 

(1) the number, type, cost, condition, 
useful life and depreciation schedule of 
all medical diagnostic equipment that 
either is proposed to be acquired or is 
currently owned or operated by the 
applicant, and will be part of the diag- 
nostic center following completion of 
the project; 

(2) other than the equipment listed in Sub- 
paragraph (b)(1) of this Rule, a list of 
all equipment and related components 
which are necessary to perform the 
proposed procedures and services; 

(3) the maximum number of procedures 
that each piece of medical diagnostic 
equipment in the diagnostic center is 
capable of performing and the assump- 
tions used to project capacity; 

(4) a list aU health service facilities that 
operate existing and have been 
approved to operate medical diagnostic 
equipment and diagnostic suites by type 
and location in the proposed medical 
diagnostic service area; 

(5) the hours of operation of the proposed 
diagnostic center and each proposed 
diagnostic service; 

(6) the patient origin by percentage by 
county of residence for each diagnostic 
service provided by the applicant m the 
12 month period immediately preceding 
the submittal of the proposal; 

(7) the projected patient origin by percent- 
age by county of residence for each 
service proposed, and all the assump- 
tions and data supporting the methodol- 
ogy used for the projections; 

(8) drawings or schematics of the proposed 
diagnostic center that identifies a dis- 



tinct, identifiable area for each of the 
proposed services; and 
(9) a three year capital budget. 

(c) An applicant proposing to establish a new 
mobile diagnostic program shall also provide the 
following information: 

(1) the number, type and cost of al] pro- 
posed mobile medical diagnostic equip- 
ment including the cost of the transport- 
ing equipment; 

(2) other than the equipment listed in Sub- 
paragraph (b)(1) of this Rule, a list of 
all equipment and related components 
which are necessary to perform the 
proposed procedures and services; 

(3) the number and type of all existing and 
approved mobile diagnostic equipment 
in the proposed mobile diagnostic cen- 
ter service area; 

(4) the maximum number of procedures 
that each proposed piece of medical 
diagnostic equipment is capable of 
performing and the assumptions used to 
project capacity; 

(5) the name, address and hours of service 
at each host facility that is proposed to 
be served by the mobile diagnostic 
program; and 

(6) copies of letters of intent from, and 
proposed contracts with, all of the 
proposed host facilities of the mobile 
diagnostic program. 

(d) An applicant proposing to establish a new or 
to expand an existing diagnostic center shall 
identify which of the following services will be 
available: 

(1) computerized tomography (CT) servic- 
es; 

(2) fluoroscopy services; 

(3) laboratory services; 

(4) mammography screening; 

(5) magnetic resonance imaging (MRI); 

(6) nuclear medicine; 

(7) positron emission tomography (PET); 

(8) diagnostic radiology; 

(9) diagnostic ultrasound imaging; and 

(10) other diagnostic services. 

(e) An applicant proposing to establish a new or 
to expand an existing diagnostic center shall 
demonstrate that the diagnostic services will be 
offered in a physical environment that conforms to 
the requirements of federal, state and local regula- 
tory bodies. 

(f) An applicant shall demonstrate that all 
equipment, su pplies and pharmaceuticals proposed 



1076 



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September 15, 1993 



PROPOSED RULES 



for the diagnostic center have been certified for 
clinical use by the U.S. Food and Drug Adminis- 
tration or will be operated or used under an institu- 
tional review board whose membership is consis- 
tent with U.S. Department of Health and Human 
Services regulations. 

Statutory Authority G.S. 131E-177(1). 

.3904 NEED FOR FACILITY 

An applicant proposing to establish a new diag- 
nostic center or to expand an existing diagnostic 
center shall provide: 

(1) the projected number of patients to be 
served, classified by diagnosis and by 
county of residence for each of the first 
twelve calendar quarters following com- 
pletion of the project; 

(2) the projected number and type of diag- 
nostic procedures proposed to be provid- 
ed by CPT code or ICD-9-CM procedure 
code for each of the first twelve calendar 
quarters following completion of the 
project: 

(3} documentation that all existing health 
service facilities providing similar medi- 
cal diagnostic equipment and services as 
proposed in the CON application in the 
defined diagnostic center service area 
were operating at 80% of the maximum 
number of procedures that the equipment 
is capable of performing for the twelve 
month period immediately preceding the 
submittal of the application; 

(4) documentation that all existing and ap- 
proved medical diagnostic equipment and 
services of the type proposed in the CON 
a pplication are projected to be utilized at 
80% of the maximum number of proce- 
dures that the equipment is capable of 
performing by the fourth quarter of the 
third year of operation after initiation of 
diagnostic services; 

(5) documentation that the applicant's utiliza- 
tion projections are based on the experi- 
ence of the provider and on epidemiolog- 
ical studies; and 

(6) all the assumptions and data supporting 
the methodologies used for the projec- 
tions in this Rule. 

Statutory Authority G.S. 131E-177(1). 

.3905 REQUIRED SUPPORT SERVICES 

An applicant shall provide documentation show- 



ing the proximity of the proposed diagnostic center 
to the following services: 

(1) emergency services; 

(2) support services; 

(3) ancillary services; and 

(4) public transportation. 

Statutory Authority G.S 131E-177(1). 

.3906 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) An applicant proposing to establish a new 
diagnostic center or to expand an existing diagnos- 
tic center shall identify the number of radiologists, 
radiation physicists, other physicians, laboratory 
staff, radiologic technologists and support staff that 
are projected to be involved in providing each of 
the proposed diagnostic services. 

(b) An applicant proposing to provide ionizing 
and nonionizing radiation procedures shall demon- 
strate that a physician, licensed to practice medi- 
cine in North Carolina who is qualified and autho- 
rized to perform radiation procedures, shall be 
available to perform and supervise all radiation 
procedures. 

(c) An applicant proposing to establish a new 
diagnostic center or to expand an existing diagnos- 
tic center shall document that a program of contin- 
uing education shall be available for technologists 
and medical staff. 

Statutory Authority G.S 131E-177(1). 

.3907 DATA REPORTING REQUIREMENTS 

The applicant shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information, in accor- 
dance with the data format and reporting require- 
ments formulated by the Division of Facility 
Services: 

(1) demographic data on patients receiving 
services; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S. 131E-177(1). 

.3908 ACCESSIBILITY 

£a] The applicant shall provide documentation 
describing the mechanism that will be used to 
insure that the projected number of medically 
underserved will be served in the facility. 

(b) The applicant shall provide written admis- 
sions policies identifying any prepayment or 
deposit requirements for the facility and stating the 



8:12 



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September 15, 1993 



1077 



PROPOSED RULES 



admission requirements for the patients in each of 
the following payor categories: 

(1) Medicare; 

(2) Medicaid; 

(3) Blue Cross and Blue Shield; 

(4) Commercial Insurance; 

(5) State Employees Health Plan; 

(6) Self Pay (includes self-pay, indigent 
and charity care); and 

(7) Other as identified by the applicant. 

(c) The applicant shall provide a written descrip- 
tion of the billing procedures, including the credit 
and collection policies that will be utilized by the 
facility. 

(d) The applicant shall document that the health 
care community in the diagnostic center service 
area, including existing current providers of 
diagnostic services, have been invited to comment 
on the proposed project, particularly with regard to 
the facility's referral mechanisms and admissions 
policies for the medically underserved. 

Statutory Authority G.S. ]31E-177(}). 

SECTION .4000 - CRITERIA AND 

STANDARDS FOR SOLID ORGAN 

TRANSPLANTATION SERVICES 

.4001 DEFINITIONS 

The following definitions shall apply to all rules 
in this Section: 

(1) "Solid organs" mean the heart, lung, 
liver, kidney, pancreas and islet cells and 
intestines. 

(2) "Pediatric Patient" means a patient under 
the age of J/T^ 

(3) "Solid Organ Transplantation Service 
Area" means a geographical area defined 
by the applicant from which patients 
projected to receis'e the services origi- 
nate. 

(4) "Solid Organ Transplantation Services" is 
defined in G.S. 131E-176( 16)(24b). 

£5] "UNOS" or the "United Network for 
Organ Sharing" means the organization 
contracted by the Department of Health 
and Human Services to operate both the 
organ procurement and transplantation 
network and the scientific registry of 
information on organ donors and recipi- 
ents. 

Statutory Authority G.S 131E-]77(1). 

.4002 INFORMATION REQUIRED OF 



APPLICANT 

(a) An applicant proposing to establish a new 
solid organ transplantation service or to expand an 
existing solid organ transplantation service shall 
use the Acute Care Facility/Medical Equipment 
application form. 

(b) An applicant proposing to establish a new 
solid organ transplantation service or to expand an 
existing solid organ transplantation service shall 
demonstrate that it meets one of the following: 

(1) the applicant is an academic medical 
center teaching hospital with accredited 
residencies or fellowships related to 
solid organ transplantation, including 
but not limited to: general surgery, 
thoracic surgery, internal medicine, and 
urology; or 

(2) the applicant has a written agreement 
with such an academic medical center 
teaching hospital under which the aca- 
demic medical center teaching hospital 
will provide technical assistance to the 
applicant. 

(c) The applicant shall provide a copy of jts 
procedures for selecting transplant candidates and 
for distributing organs which are consistent with 
UNOS guidelines. 

(d) The applicant shall provide letters of agree- 
ment or contracts \».'ith either an independent organ 
procurement organization or a hospital-based organ 
procurement organization. The letters shall dem- 
onstrate the capability to provide sufficient num- 
bers of organs to support the minimum activity 
level for the applicable type of organ transplanta- 
tion proposed in the application. 

(e) The applicant shall document collaboration 
with experts in the fields of hepatology. cardiolo- 
gy, pediatrics, infectious disease, nephrology, 
renal dialysis, pulmonary medicine, respiraton,' 
therapy, pathology, immunology, anesthesiology, 
physical therapy, and rehabilitation. The docu- 
mentation shall include, but not be limited to. a 
plan of operation detailing the interaction of the 
transplant ser\'ice and the stated special t\- areas. 

(f) An applicant that proposes to establish a joint 
sharing arrangement for organ transplantation 
services which involves more than one hospital 
shall demonstrate all of the following: 

(1) all hospitals in the joint sharing 
arrangement are geographically 
proximate to permit cost-efFective 
sharing of resources; and 

(2) a single hospital site has been 
designated where the organ transplant 
surgical procedures will be performed 



1078 



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September 15, 1993 



PROPOSED RULES 



which involves both adult and pediatric 
organ transplant procedures, except one 
hospital site may be designated where 
all aduh organ transplant procedures 
will be performed and another hospital 
site may be designated where all 



pediatric organ transplant procedures 

will be performed if both hospital sites 

are part of the joint sharing 

arrangement. 

(g) The applicant shall demonstrate that 

transplantation services will be offered in a 

physical environment that conforms to the 

requirements of federal, state and local bodies. 

(h) An applicant proposing to establish a new 
solid organ transplantation service or to expand an 
existing solid organ transplantation service shall 
include drawings or schematics of the proposed 
project that identify the location of the operating 
rooms in the hospital where transplantation 
procedures will be performed. 

(i) An applicant proposing to establish a new 
solid organ transplantation service or to expand an 
existing solid organ transplantation service shall 
project the number and type of transplantations by 
CPT code or ICD-9-CM procedure code by 
distinct transplantation service for each of the first 
twelve calendar quarters following completion of 
the proposed project. 

£i} An applicant proposing to establish a new 
solid organ transplantation service or to expand an 
existing solid organ transplantation service shall 
project patient origin by state and by county for 
North Carolina residents and shall indicate the 
percentage of total patients to originate from each 
State and county. 



Statutory Authority G.S. 131E-177(1). 

.4003 REQUIRED SUPPORT SERVICES 

An applicant proposing to establish a new or to 
expand an existing solid organ transplantation 
service shall demonstrate that it offers all of the 
following items: 

(1) operating and recovery room resources; 

(2) intensive care facilities allowing reverse 
isolation; 

("3") microbiology and virology laboratory; 

(4) laboratory facilities for histocompatibility 
testing that are certified by the American 
Society for Histocompatibility and 
Immunogenetics; 

(5) a multidisciplinary plan for providing 
rehabilitation; 

(6) CT scanning; 



01 
£8} 
I9i 

(10) 
OH 
(12) 
(13) 



nuclear medicine; 
magnetic resonance imaging; 
duplex ultrasound scanning for liver, 
pancreas and kidney transplantation; 
pulmonary medicine; 
cardiology; 

an acute hemodialysis unit; 
a state certified social worker with a 

is 



master's degree in social 
available for inpatient 



work who _ 
and outpatient 



(14) 



(15) 



(16) 

(17) 

(18) 
(19) 



(20) 
(21) 



ongoing sup port of both the patient and 

family; 

a licensed practicing psychologist or 

licensed psychological associate who ]s 

available for inpatient and outpatient 

ongoing su pport of both the patient and 

family; 

a psychiatrist who is available for 

inpatient and outpatient ongoing support 

of both the patient and family; 

full-time organ transplant coordinator(s); 

an on-going program of community-based 

post-transplantation care; 

basic and clinical laboratory research; 

an active, formal research program 

related to the proposed organ 

transplantation service; 

an established organ donation protocol. 

with brain death protocol, consistent with 

North Carolina law; and 

an established program to promote organ 

donation at the applicant's hospital. 



the Statutory Authority G.S. 131E-177(1). 



.4004 ADDTL REQ, FOR HEART, 
HEART/LUNG OR LUNG 
TRANSPLANTATION SERVICES 

(a) An applicant proposing to establish a new 
heart, heart/lung or lung transplantation service 
shall document that no more than two (2) heart, 
heart/lung or lung transplanfation services shall be 
located in the same solid organ transplantation 
service area following completion of the project. 

(b) An applicant that proposes to establish a new 
heart, heart/lung or lung transplantation service 
shall project a cumulative minimum of 20 heart, 
heart/lung or lung transplantation procedures by 
the end of the second full year of operation 
following the date on which the first heart, 
heart/lung or lung transplant procedure is 
performed. 

(c) An applicant proposing to establish a new 
heart, heart/lung or lung transplantation service or 
to expand an existing heart, heart/lung or lung 



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September 15, 1993 



1079 



PROPOSED RITES 



transplantation service shall demonstrate that it 
offers all of the following services: 

(1) a histocompatibility laboratory, or a 
written agreement with such a 
laboratory; 

(2) anatomic and clinical pathology with an 
approN'ed residency program; 

(3) 24-hour angiography; 

(4) an intensive care unit with 24-hour per 
day resident coverage; 

(5) a continuously available coagulation 
laboratory; and 

(6) a blood bank capable of providing 20 
units of blood, platelets, and fresh 
blood products on demand. 

Statutory^ Authority G.S. 131E-177(1). 

.4005 ADDITIONAL REQUIREMENTS FOR 
LIVER TRANSPLANTATION 
SERVICES 

(a) An applicant proposing to establish a new 
liver transplantation service or to expand an 
existing liver transplantation service shall 
document that no more than 2 liver transplantation 
services shall be located in the same solid organ 
transplantation service area following completion 
of the project. 

(b) An applicant proposing to establish a new 
liver transplantation service shall project a 
cumulati\'e minimum of 15 liver transplantation 
procedures by the end of the second full year of 
operation following the date on which the first 
liver transplant procedure is performed. 

(c) An applicant proposing to establish a new 
liver transplantation service or to expand an 
existing liver transplantation service shall 
demonstrate that it either: 



m 

12) 



operates an existing renal transplant 
service; or 

has a written agreement with a renal 

transplant service that ensures that the 

professional expertise of the renal 

transplant service is readily available to 

the proposed liver transplantation 

service. 

(d) An applicant proposing to establish a new 

liver transplantation service or to expand an 

existing liver transplantation service shall 

demonstrate that it offers all of the following 

items: 

a histocompatibility laboratory, or a 
v.Titten agreement v.ith such a laboratory'; 
anatomic and clinical pathology with an 
appro\ed residency program; 



(3) 24-hour angiography; 

(4) an intensive care unit with 24-hour per 
day resident coverage; 

(5) veno-venous bypass equipment that 
does not require heparin; 

(6) adult and pediatric (as appropriate) 
gastroenterologists and hepatologists on 
the active medical staff who meet 
UN OS criteria for transplant physicians 
and surgeons; 

(7) endoscopic retrograde 
cholangiopancreatography (ERCP) 
availability; 

percutaneous cholangiogram 
availability; 

a rapid blood infusion system; 
percutaneous liver biopsy capability: 
hemoperfusion; 

a rapid red blood cell (RBC) saver 
s\'stem : and 
duplex ultrasound. 

applicant shall establish and maintain all 
owing: 



(8) 

iil 
(10) 

im 

(12) 

Oil 

ie] Ihe 

of the foil 

m 

121 
iil 



m 

121 



nuclear HID biliary scan availability; 
continuously available coagulation 
laboratory; and 

a blood bank system capable of 
providing 200 units of blood or packed 
cells. 1(X) units of plasma on demand. 
24 units (or four adult doses) of platelet 
concentrates and 30 units of 
cryoprecipate on demand. 



Statutory Authority G.S. 131E-177(1). 

.4006 ADDITIONAL REQUIREMENTS FOR 
PANCREAS TRANSPLANTATION 
SERVICES 

(a) An applicant proposing to establish a new 
pancreas transplantation service or to expand an 
existing pancreas transplantation service shall 
document that no more than 2 pancreas 
transplantation services shall be located in the 
same solid organ transplantation service area 
following completion of the project. 

(b) An applicant proposing to establish a new 
pancreas transplantation service or to expand an 
existing pancreas transplantation service shall 
project a cumulative minimum of 10 pancreas 
transplantation procedures by the end of the second 
full year of operation following the date on which 
the first pancreas transplant procedure is performed. 

(c) An applicant proposing to establish a new 
pancreas transplantation service or to expand an 
existing pancreas transplantation service shall 



1080 



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September 15, 1993 



PROPOSED RULES 



demonstrate that it offers all of the following 
services: 

(1) a histocompatibility laboratory, or a 
written agreement with such a 
laboratory; 

(2) anatomic and clinical pathology; 

(3) 24-hour angiography; 

(4) an intensive care unit with 24-hour per 
day resident coverage; 

(5) approved on-site renal transplant 
services; 

(6) physicians with rehabilitation expertise; 

(7) both adult and pediatric surgeons, as 
appropriate; and 

(8) both adult and pediatric diabetologists, 
as appropriate, on the active medical 
staff. 

(d) The applicant shall establish and maintain all 
of the following: 

(1) insulin, 

(2) C-peptide, 

(3) glycosylated hemoglobin assays; and 

(4) glucometer glucose assays. 

Statutory Authority G.S. 131E-177(1). 

.4007 ADDITIONAL REQUIREMENTS FOR 
KIDNEY TRANSPLANTATION 
SERVICES 

(a) An applicant proposing to establish a new 
kidney transplantation service or to expand an 
existing kidney transplantation service shall 
document that no more than 2 kidney 
transplantation services shall be located in the 
same solid organ transplantation service area 
following completion of the project. 

(b) An applicant proposing to establish a new 
kidney transplantation service shall project a 
cumulative minimum of 50 transplantation 
procedures by the end of the second full year of 
operation following the date on which the first 
transplant procedure is performed. 

(c) An applicant proposing to establish a new 
kidney transplantation service or to expand an 
existing kidney transplantation service shall 
demonstrate that it provides all of the following: 

(1) a histocompatibility laboratory, or a 
written agreement with such a 
laboratory; 

an intensive care unit with 24-hour per 
day resident coverage; 
inpatient renal dialysis services; 
available freestanding renal dialysis 
clinic services; 

dialysis and post- 



transplantation nutritional services; 

(6) bacteriologic services; 

(7) biochemical services; 

(8) pathological services; 

(9) radiologic services; and 

(10) ophthalmology retinal eye services. 

Statutory Authority G.S. 131E-177(1). 

.4008 ADDITIONAL REQUIREMENTS FOR 
INTESTINE TRANSPLANTATION 
SERVICES 

An applicant proposing to establish a new 
intestine transplantation service or to expand an 
existing intestine transplantation service shall 
document that no more than two intestine 
transplantation services shall be located in the 
same solid organ transplantation service area 
following completion of the project. 

Statutory Authority G.S 131E-177(1). 

.4009 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) An a pplicant proposing to establish a new 
heart, heart/lung or lung transplantation service or 
to expand an existing heart, heart/lung or lung 
transplantation service shall demonstrate that the 
following persons shall provide the proposed 
services: 



ill 

i2l 
O) 
(41 
15} 



12) 

£3} 
(41 



(5) pre-dialysis. 



anesthesiologists with expertise in 
transplantation anesthesia; 
cardiologists and surgeons trained in 
endocardial biopsy and 
immunosuppression techniques; 
cardiologists and surgeons for both 
adult and pediatric patients, as 
appropriate; 

surgeons and physicians that meet 
UNOS criteria as transplant physicians 
and surgeons; and 

a nursing team trained in 

immunosuppression management 

including isolation techniques and 

infection control methods. 

(h) An applicant proposing to establish a new 

liver transplantation service or to expand an 

existing liver transplantation service shall 

demonstrate that the following persons shall 

provide the proposed services: 

(1) anesthesiologists with expertise in 
transplantation anesthesia; 

(2) surgeons and physicians who meet 
UNOS criteria as liver transplant 
surgeons and physicians; 



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September 15, 1993 



1081 



PROPOSED RULES 



m 



141 



a veno-venous bypass team immediately 
available for liver transplant recipient 
operation, a requirement which may be 
satisfied by a written agreement which 
ensures that a veno-venous bypass team 
will always be on site throughout the 
entire liver transplant recipient 
operation; and 

a nursing team trained i_n 
immunosuppression management 
including isolation techniques and 
infection control methods. 



(c) An applicant proposing to establish a new 
pancreas transplantation service or to expand an 
existing pancreas transplantation service shall 
demonstrate that the following persons shall 
provide the proposed services: 

(1) anesthesiologists with expertise in 
transplantation anesthesia: 

(2) transplant surgeons and physicians 
experienced with renal transplantation 
in diabetics; 

(3") surgeons and physicians who meet 

UNOS criteria as pancreatic transplant 

surgeons and physicians; 
(4) adult and pediatric diabetologists. as 

appropriate, actively participating in the 

transplant service; and 
£5} a nursing team trained i_n 

immunosuppression management 

including isolation techniques and 

infection control methods. 

(d) An applicant proposing to establish a new 
Iddney transplantation service or to expand an 
existing kidney transplantation service shall 
demonstrate that the following persons shall 
provide the proposed services: 

(1) surgeons and physicians that meet 
UNOS criteria as kidney transplant 
surgeons and physicians; 

(1) the transplant team performing kidney 
transplantation shall include physicians 
in the areas of anesthesiology, 
nephrology. psychiatry, vascular 
surgery and urology; 

(3) additional support personnel shall be 
available including but not limited to a 
nephrology nurse with experience m the 
nursing care of patients with permanent 
kidney failure and a renal dietician; 

(4) adult and pediatric diabetologists. as 
appropriate, actively participating in the 
transplant service; 

(5) a nursing team trained in immunosup- 
pression management including isola- 



tion techniques and infection control 

methods, 
(e) An applicant proposing to establish a new 
intestine transplantation service or to expand an 
existing intestine transplantation service shall 
demonstrate that the following persons shall 
provide the proposed services: 

(1) anesthesiologists with expertise in trans- 
plantation anesthesia; 

(2) surgeons and physicians that meet 
UNOS criteria as transplant surgeons 
and physicians; 

(3) a physician who meets UNOS criteria 
in the sub-specialty of Gastroenterolo- 

gy; 

(4) a pathologist who is certified by the 
American Board of Pathology or who 
has equivalent qualifications; and 

(5) a nursing team trained in immunosup- 
pression management including isola- 
tion techniques and infection control 
methods. 

Statutory Authority G.S. 131E-177(1). 

.4010 NEED FOR SERVICES 

The applicant shall provide a description of the 
data sources used to project utilization, assess- 
ments of the accuracy of the data, the statistical 
method used to make the projections, the expected 
volume of organs that will be available for trans- 
plantation and the anticipated relationship between 
projected volumes and patient outcomes. This 
information shall be set out separately for each 
type of solid organ transplantation service that the 
applicant proposes to offer. 

Statutory Authority G.S. 131E-177(1). 

.401 1 DATA REPORTING REQUIREMENTS 

The applicant shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information, in accor- 
dance with data format and reporting requirements 
formulated by the Division of Facility Services: 

(1) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S. 131E-177(1). 

.4012 ACCESSIBILITY 

(a) An applicant proposin g to establish a new 
solid organ transplantation service or expand an 
existing solid organ transplant service shall docu- 



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PROPOSED RULES 



ment the procedures that will be used to ensure 
that patient selection criteria is public, fair and 
equitable with primary screening based on medical 
suitability which is designed to offer transplanta- 
tion to those who can benefit the most from it in 
terms of probability of living for a significant 
period of time with a reasonable prospect of 
rehabilitation. 

(h) The applicant shall provide written admis- 
sions policies identifying any prepayment or 
deposit requirements for the facility and stating the 
admission requirements for patients in each of the 
following payor categories: 



m 

13} 
14} 
15} 
16} 



Medicaid; 



indigent 



01 



Medicare; 

Blue Cross and Blue Shield; 

Commercial Insurance; 

State Employees Health Plan; 

Self-Pay (includes self-pay. 

and charity care); and 

Other as identified by the applicant. 

(c) The applicant shall provide a written descrip- 
tion of the billing procedures, including the credit 
and collection policies, that will be utilized by the 
facility. 

(d) The applicant shall describe the procedures 
for the referral of patients from one institution to 
another institution when space, personnel or other 
limitations prevent the referring institution from 
timely serving the patient's needs. 

(e) The applicant shall document that the health 
care community in the solid organ transplantation 
service area, including all providers of solid organ 
transplantation services and organ procurement 
organizations |n North Carolina have been invited 
to comment on the proposed project, particularly 
with regard to the facility's referral mechanisms 
and admissions policies for the medically 
underserved. 

(f) An applicant proposing to establish a new 
solid organ transplantation service or to expand an 
existing solid organ transplantation service shall 
provide documentation describing the mechanism 
for donor/patient compatibility that will be used to 
ensure that the uninsured and medically 
underserved will have access to solid organ 
transplantation services. 

Statutory Authority G.S. 131E-177(1). 

SECTION .4100 - CRITERIA AND 
STANDARDS FOR PEDIATRIC INTENSIVE 
CARE SERVICES 

.4101 DEFINITIONS 



The definitions in this Rule shall apply to all 
rules in this Section: 

(1) "Pediatric intensive care service area" 
means a geographic area defined by the 
applicant from which the patients to be 
admitted to the unit will originate. 

(2) "Pediatric intensive care services" means 
those services provided by an acute care 
hospital to children with a wide variety 
of illnesses of a life-threatening nature, 
including children with highly unstable 
conditions requiring sophisticated medical 
and surgical intervention, children 
requiring a high level of nursing care and 
those children requiring continuous, 
comprehensive observation. 

(3) "Pediatric intensive care unit" means a 
separate self-sufficient entity that contains 
supplies and equipment essential to 
provide treatment on a 24-hour basis to 
children who need pediatric intensive 
care services. It does not include post- 
operative recovery rooms, post-delivery 
rooms, or emergency observation units. 

£4} "Perinatal region" means a geographic 
area of the state as established by the 
Perinatal Council. A list of the perinatal 
regions may be obtained from the 
Division of Maternal and Child Health. 
Department of Environment, Health and 
Natural Resources. 1330 St. Mary's 
Street. Raleigh, NC. 27605-3248. 



Statutory Authority G.S. 131E-177(1). 

.4102 INFORMATION REQUIRED OF 
APPLICANT 

(a) An applicant proposing to develop a new 
pediatric intensive care unit or to add a bed to an 
existing pediatric intensive care unit shall use the 
Acute Care Facility/Medical Equipment application 
form. 



(b) The applicant shall also submit the following 
additional information: 

(1) the number of designated pediatric 
intensive care beds currently operated 
by the applicant and the number of 
designated pediatric intensive care beds 
to be operated following completion of 
the proposed project; 

(2) documentation of the applicant's 
experience in treating pediatric patients 
at its facility during the past twelve 
months, including: 

(A) the number of pediatric trauma 



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1083 



PROPOSED RULES 



patients provided emergency room 
services; 

(B) the number of pediatric patients 
provided ambulatory surgery services; 

(C) the number of inpatient days of care 
provided to pediatric patients; and 

(D) the number of pediatric patients 
treated and referred to a pediatric 
intensive care unit in another facility; 

(3) the number of patients, by county of 
residence, in the proposed pediatric 
intensive care service area that are 
projected to need pediatric intensive 
care services in each of the first twelve 
quarters of operation following the 
completion of the project; also, all 
assumptions and methodologies for 
projecting need shall be stated; 

(4) the projected number, by county of 
residence, of those patients identified in 
response to item (3) of this Rule that 
are projected to be served in the 
a pplicant's facility jn each of the first 
twelve calendar quarters following 
completion of the proposed project; 
also, all assumptions and methodologies 
for projecting utilization shall be stated; 

(5) documentation that at least 90 percent 
of the anticipated patient population is 
within 90-minute automobile driving 
time one-way from the facility, unless 
the applicant demonstrates that its 



IB] 



facility provides: 
specialized levels 



of pediatric 



intensive care services to a large and 
geographically diverse population, or 
air ambulance services; 

(6) documentation that the existing and 
approved pediatric intensive care units 
in the same perinatal region and 
adjacent perinatal regions are unable to 
accommodate the projected need for 
pediatric intensive care services; 

(7) documentation that the services shall be 
offered in conformance with the 
requirements of federal . state, and local 
regulatory bodies; 

(8) correspondence from physicians, 
hospitals, or other health care facilities 
documenting their intent to refer 
patient's to the applicant's pediatric 
intensive care unit; 

(9) evidence of the applicant's capability to 
communicate effectively with 
emergency transportation agencies; 



(10) copies of written policies that provide 
for parental participation in the care of 
the child, as the child's condition 
permits, in order to facilitate family 
adjustment and continuity of care 
following discharge; 

(11) copies of written policies and 
procedures regarding the operation of 
the pediatric intensive care unit, 
including but not limited to the 
following: 

the admission and discharge of 

patients; 

infection control; 



lAl 

IB) 
IC] 
ID] 



(12) 



(13) 
(14) 



safety procedures; and 

the tnaging of patients requiring 

consultations, including the transfer of 

patients to another facility; 
documentation that the proposed service 
shall be operated in an area of the 
facility that is organized as a physically 
and functionally distinct entity and that 
has controlled access; 
a detailed floor plan of the proposed 

be 

able to observe all patients from one 
vantage point- 



area drawn to scale; and 
documentation that unit staff shall 



Statutory Authority G.S. 13} £-177(1). 

.4103 REQUIRED PERFORMANCE 
STANDARDS 

An applicant proposing to develop a new 

pediatric intensive care unit or to add a bed to an 

existing pediatric intensive care unit shall 

demonstrate that the following standards are met: 

(1) the overall average annual occupancy rate 

for the twelve months immediately 

preceding the submittal of the proposal of 

the number of beds in the applicant's 

existing pediatric intensive care unit shall 

have been at least 70 percent in units 

with 20 or more pediatric intensive care 

beds, 65 percent m units with 10-19 

pediatric intensive care beds, and 60 

percent in units with 1-9 pediatric 



intensive care beds; 



12] 



the projected annual occupancy rate of 
the applicant's proposed pediatric 
intensive care unit in the third year of 
operation following completion of the 
proposed project shall be at least 70 
percent in units with 20 or more pediatric 
intensive care beds, 65 percent in units 



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September 15, 1993 



PROPOSED RULES 



with 10-19 pediatric intensive care beds, 
and 60 percent in units with 1-9 pediatric 
intensive care beds; and 
(3) the applicant shall document all 
assumptions and provide data supporting 
the methodology used for each of the 
projections required in this Rule. 

Statutory Authority G.S. 131E-177(1). 

.4104 REQUIRED SUPPORT SERVICES 

(a) An applicant proposing to develop a new 
pediatric intensive care unit or to add a bed to an 
existing pediatric intensive care unit shall 
document that the following items shall be 
available; except that if an item shall not be 
available, then documentation shall be provided 
obviating the need for that item: 

(1) twenty-four hour laboratory services 
including microspecimen chemistry 
techniques and blood gas 
determinations; 

(2) twenty-four hour radiology services, 
including portable radiological 
equipment; 

twenty-four hour blood bank services; 
twenty-four hour pharmacy services; 
twenty-four hour respiratory therapy 
services; 



(17) pediatric expertise in the following 



(3) 
£4} 
15} 

16} 

£8] 
121 

(10) 



twenty-four hour CT scanning services: 
EEG testing capability; 
oxygen and air and suction capability; 
cardiovascular monitoring capability 
with alarm capacity; 
mechanical ventilatory assistance equip- 
ment including airways, manual breath- 
ing bag, ventilator and respirator of 
pediatric patient size; 

(1 1) endotracheal intubation capability; 

(12) a cardiac arrest management plan; 

(13) a patient weighing device for bed pa- 
tients; 

(14) isolation capability; 

(15) a designated social worker; 

(16) consultation with the following medical 
subspecialties: 

(A) Pediatric Cardiology and cardiology 
diagnostic services; 

(B) Pediatric Surgery or surgeons with 
training or interest in pediatrics, 
including neurosurgery, otolaryngolo- 
gy and cardiothoracic surgery; 

(C) Pediatric Neurology; and 

(D) other pediatric subspecialties as re- 
quired; and 



(b) 



ill 



(2) 



(A) physical therapy; 

(B) occupational therapy; 

(C) speech therapy; and 

(D) dietary support. 
An applicant shall describe the types of 

patient care monitoring that shall be available to 
meet the specific needs of each type of patient that 
the applicant proposes to serve. 

Statutory Authority G.S. 131E-177(1). 

.4105 REQUIRED STAFFING AND STAFF 
TRAINING 

(a) An applicant proposing to develop a new 
pediatric intensive care unit or to add a bed to an 
existing pediatric intensive care unit shall demon- 
strate that the following staffing requirements will 
be met: 

nursing care shall be supervised by a 
registered nurse with specialized train- 
ing ijQ patient care monitoring and life 
support; 

direction of the unit shall be provided 
by a physician with training, experience 
and expertise in critical care; and 
(3) documentation from the medical staff 
confirming that pediatricians and sur- 
geons of at least the resident or staff 
level shall be in the facility twenty-four 
hours per day. 

(b) An applicant shall document that inservice 
training or continuing education programs specific 
to pediatric intensive care services shall be provid- 
ed to the pediatric intensive care staff and shall 
describe the inservice training and continuing care 
programs which shall be offered. 

Statutory Authority G.S I31E-177(1). 

.4106 DATA REPORTING 
REQUIREMENTS 

The facility shall agree to provide, upon the 
request of the Division of Facility Services, the 
following types of data and information, in accor- 
dance with data format and reporting requirements 
formulated by the Division of Facility Services: 

(1) demographic data on patients treated; 

(2) financial data; and 

(3) clinical data. 

Statutory Authority G.S 131 £-177(1). 
.4107 ACCESSIBILITY 



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September 15, 1993 



1085 



PROPOSED RULES 



(a) The applicant shall provide documentation 
describing the mechanism that shall be used to 
insure that the projected number of medically 
undersen.'e<d shall be served in the unit. 

(b) The applicant shall provide a copy of the 
written admissions policies identifying any prepay- 
ment or deposit requirements for the facility and 
stating the admissions requirements for each of the 
following payor categories: 



m 

121 

14} 
15] 
16) 



Medicare; 

Medicaid; 

Blue Cross and Blue Shield; 

Commercial Insurance; 



indigent 



m 



State Employees Health Plan; 
Self-Pay (includes self-pay, 
and charity care); and 
Other as identified by the applicant. 

(c) The applicant shall provide a written descrip- 
tion of the billing procedures, including the credit 
collection policies, that shall be utilized by the 
facility. 

(d) The applicant shall document that the health 
care community in the "pediatric intensive care" 
service area, including the Departments of Social 
Services and Health, have been invited to comment 
on the proposed project, particularly with regard to 
the facility's referral mechanisms and admissions 
policies for the medically underserved. 

Statutory Authority G.S. 131E-177(1). 

iSotice is hereby given in accordance with G.S. 
150B-21.2 that the Commission for Mental Health. 
Developmental Disabilities and Substance Abuse 
Services intends to amend rules cited as 10 NCAC 
14J .0206 and 10 NCAC ML .0602, with changes 
from the proposed text of 10 NCAC 14J .0206 
noticed in the Register, Volume 8, Issue 7, pages 
545 - 549 and 10 NCAC 14L .0602 noticed in 
Volume 8. Issue 5, pages 413 - 414. 

1 he proposed effective date of this action is 
January 4, 1994. 

txeason for Proposed Action: 
10 NCAC 14J .0206 - To reinsert a portion of the 
Rule which was inadvertently omitted during 30- 
day notice of initial amendment , clarif\ing proce- 
dures for use of Seclusion, Restraints, or Isolation 
time out. 
10 NCAC 14L .0602 - To provide public notice of 



changes made during the public hearing regarding 
licensure of Residential Treatment Facilities. 

(comment Procedures: Written comments may be 
submitted to Charlotte Tucker, Division of Mental 
Health, Developmental Disabilities and Substance 
Abuse Services, Albemarle Building, 325 N. 
Salisbury Street, Raleigh, NC 27603. These 
comments will be accepted from September 15, 
1993 through October 15, 1993. 

hiditor's Note: An agency may not adopt a rule 
that differs substantially from the text of a pro- 
posed rule published in the Resister, unless the 
agency publishes the text of the proposed differ- 
ent rule and accepts comments on the new text 
for at least 30 days after the publication of the 
new text. 

CHAPTER 14 - MENTAL HEALTH: 
GENERAL 

SUBCHAPTER 14J - TREATMENT OR 
HABILITATION RIGHTS 

SECTION .0200 - PROTECTIONS 
REGARDING CERTAIN PROCEDURES 

.0206 PROCEDURES: SECLUSION. 
RESTRAINTS, OR ISOLATION 
TIME OUT 

(e^ The interventions specified in this Rule 

present a significant risk to the client and therefore 
requir e additional safeguards. — These procedures 
shall be followed in addition to the procedures 
specified in Rule .0203 of this Section. 

(b) TTic following interventions are designed for 
the primary' purpose of reducing the incidence of 
aggressive, dangerous or self injurious behavior to 
a level which will allow the use of less intrusive 
tr e atment/habilitntion procedures. — Such intervcn 
tions include the use of: 

f4-) seclusion, restraints, or isolation time 

out employed as a measure of thenif)cu 
tic treatment; 

iOr) seclusion, restramts. or i s olation time 

out u s ed on an emergency basis more 
than 4 hours in a calendar month or 
more than one episode of 2 4 hours; 

f^3 unpleasant ta s ting foodstuff's; 

f4^ planned non attention to specific unde 

sirnble behaviors when the target be 
havior is health threatening; 



1086 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



i^ contingent — d o privation — ef — any — basio 

n e o e ssity; 

(6) oontingont application of any noxious 

flubotanooo wiiioh include but ar e not 
limited to noio e , bad a m e ll o or oplash 
ing with wat e r; and 

(7) any potentially phy s ically painful proo e 

dure or stimulus which is administ e r e d 
to the client for th e purpo se of r e ducing 
the fr e qu e ncy or int e nsity of a b e hav 
iefr 
(e^ — Such interventions shall n e v e r b e th e sol e 
tr e atm e nt modality for th e elimination of target 
b e havior. Th e intervention shall alway s b e acoom 
pani e d by positive tr e atm e nt or habilitation m e th 
ods which include th e d e lib e rat e t e aching and 
reinforcement of behaviors which ar e non injuri 
oub; th e improvem e nt of conditions associat e d with 
non injurious b e haviors such as an e nrich e d e duoa 
tional and social environm e nt; and th e alteration or 
e limination of environm e ntal conditions which ar e 
r e liably correlated with s e lf injury. 

(d^ — Prior to the implementation of any plann e d 
«se — of th e — int e rv e ntion — the — following — writt e n 
approvals and notification s s hall b e obtained and 
document e d in the cli e nt r e cord: 

f4^ the — treatm e nt/habilitation — team — shall 

approve th e plan; 

(3) each cli e nt whose treatment/habilitation 

plan includ e s interventions with reason 
ably for e s ee able phy s ical con se qu e nc es 
shall rec e iv e an initial m e dical e xamina 
tion and periodic plann e d monitoring by 
a physician: 

(5) the — treatm e nt/habilitation — team — shall 

inform th e internal client advocat e that 
the intervention has b e en planned for 
the client and th e rat i onale for utiliza 



¥h- 



tion of th e int e rv e ntion. 
-the — treatm e nt/habilitation — team 



shaH 



e xplain th e int e rv e ntion and th e r e ason 
for the int e rvention to the cli e nt and th e 



legally 



ifek- 



(§)- 



r e sponsibl e person, ir applica 
feie^ — The prior written con s ent of th e 
client or his legally r e sponsibl e person 
shall be obtain e d except for thos e situa 
tions sp e cifi e d in Rul e .020 4 (h)(1) in 
this S e ction. — If the client or legally 
r e sponsibl e p e rson, if applicabl e , r e fus 
es th e int e rvention, the Stat e Facility 
Dir e ctor shall follow the right to refu se 
tr e atm e nt proc e dure s a s s p e cifi e d in this 
Subchapt e r. 
Th e — plftH — shall — be — revi e w e d — and 



d es ignat e d by th e State Facility Diroc 
teft — At least one member of the revi e w 
committ e e shall b e qualified through 
e xp e ri e nce and training to utilize the 
planned intervention. — No m e mb e r of 
the r e vi e w committ ee shall be a mem 
b e r of th e cli e nt's tr e atment tcom. 

(6) Th e tr e atm e nt/habilitation plan may bo 

r e vi e w e d and — approved — by th e State 
Facility Dir e ctor, at his option. 

(?) If any of th e p e rsons or committees 

sp e cifi e d in Subparagraphs (d)(1), (2), 
(1), (5), or (6) of this Rul e do not 
approv e th e continued use of a plann e d 
int e rv e ntion, th e plann e d int e rvention 
shall be t e rminat e d. — The State Facility 
Director shall e s tabli s h an appeal mech 
anism for th e resolution of any dis 
agr e em e nt over th e us e of th e int e rv e n 

^e) N e ith e r th e cons e nts nor th e approvals 

sp e cifi e d in Paragraph (d) of this Rul e shall be 
consider e d valid for mor e than six months. — The 
treatment/habilitation team s hall r e e valuate th e use 
of th e int e rv e ntion and obtain th e cli e nt's and 
l e gally r e sponsibl e p e rson's consent for continu e d 
use of th e int e rvention. 

(f) Th e plan shall b e revi e w e d at the next meet 
ing of th e Human Rights Committ ee within the 
constraints of 10 NCAC 1 4 G .0209. The Commit 
t ee , by majority vote, may r e comm e nd approval or 
disapproval of the plan to the State Facility Direc 
tor of may abstain from malcing a r e commenda 
tiea^ — If th e Stat e Facility Dir e ctor do e s not agr ee 
with the decision of th e Committee, the Committee 
may app e al th e issu e to th e Division in accordance 
with the provision s of 10 NCAC 1 4 G .020 8 . 

(g) TTie interv e ntion s hall be us e d only when the 
treatment/habilitation — team — has — determin e d — and 
document e d in th e cli e nt r e cord th e following: 

fl-) that th e cli e nt is engaging in behaviors 

that ar e lik e ly to result in injury to s e lf 
or oth e r s ; 

{3) that — oth e r — m e thods — of treatment — ef 

habilitation — e mploying — less — intrusiv e 
int e rventions ar e not appropriat e ; 

{^) the fr e qu e ncy, intensity and duration of 

th e targ e t b e havior, and th e b e havior' s 
probabl e ant e c e d e nts and consequ e nc e s; 



W- 



-^wtt 



approv e d — by — a — r e view — committ e e 



it is lik e ly that the int e rv e ntion 
e nable th e client to — stop th e targ e t 
behavior. 
%^ — Th e tr e atment/habilitation team s hall d es ig 
nat e a stat e facility e mploy e e to maintain accurat e 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1087 



PROPOSED RULES 



and up to dat e writt e n r e cords on th e application of 
th e int e rv e ntion and accompanying po s itiv e proo e 
dur e s. — Those records shall includ e at a minimum 
the following: 

f4^ data which r e fl e ct the fr e qu e ncy, int e n 

sity and duration with which th e targ e t 
cd behavior occurs (sci e ntific sampling 
proooduroo are acceptabl e ); 

^ data which r e fl e ct th e fr e qu e ncy, int e n 

sit^' and duration of the intervention and 
any accompanying positiv e proc e dur e s; 

i^ date — which — r e fl e ct — the — state — facility' 

employees who admini s t e r e d th e inter 
ventions. 

(+^ — The int e rv e ntions shall b e evaluat e d at least 
w ee kly by th e treatm e nt team or its d e sign ee and 
at least monthly by th e Dir e ctor of Clinical S e rvio 
es or th e Stat e Facility Dir e ctor. — Th e d e sign ee of 
th e Stat e Facility Dir e ctor or Dir e ctor of Clinical 
S e rvic e s shall not be a m e mb e r of the cli e nt's 

tr e atm e nt/habilitation — team. R e vi e ws — shall — be 

docum e nted in th e cli e nt r e cord. 

^f) During the us e of th e int e rv e ntion, th e 

Human — Rights — Committ ee — shaH — b e giv e n — the 
opportunity to r e vi e w th e treatm e nt/ habilitation 
plan within th e constraints of 10 NCAC — WG 
.0209. 

(a) This Rule delineates the procedures to be 
followed for use of seclusion, restraints, or isola- 
tion time out in addition to the procedures speci- 
fied in Rule .0203 of this Section. 

(b) This Rule governs the use of physical or 
behavioral interventions which are used to termi- 
nate a behavior or action in which a client is in 
imminent danger of iniur\' to self or other persons 
or when substantial property damage js occurring. 
or which are used as a measure of therapeutic 
treatment. Such interventions include seclusion, 
isolation time out, and mechanical restraints listed 
in Subparagraphs (a)(1). (2) and (3) of Rule .0203 
of this Section. 

(c) Seclusion, restraints, or isolation time out 
may only be used when other less restrictive 
alternatives are not feasible, as delineated In Rules 
.0204 and .0205 of this Section. 



(d) If determined to be acceptable for use within 
the state facility, the State Facility director shall 
establish written policies and procedures that 
goN'em the use of seclusion, restraints, or isolation 
time out which shall include the following: 

(1) techniques for seclusion, restraints, or 
isolation time out which are written and 
approved; 

(2) provision, to both new clinical and 






habilitation stafl^ as part of in-service 
training, and as a condition of contin- 
ued employment, for those authorized 
to use or apply intrusive interventions 
which shall include, but not be limited 
to: 
competency-based training and period- 
ic reviews on the use of seclusion. 



restraints, or isolation time out; and 
skills for less intrusive interventions 
specified in Rules .0203 and .0204 of 
this Section; 

(3) process for identifying and privileging 
state facility employees who are author- 
izzed to use such interventions; 

(4) provisions that a qualified or responsi- 
ble professional shall: 

(A) meet with the client and review the 
use of the intervention as soon as 
possible but at least within one hour 
after the initiation of its use; 

(B) verify the inadequacy of less restric- 
tive intervention techniques; 

(C) document in the client record evi- 
dence of approval or disapproval of 
continued use; and 

(D) inspect to ensure that any devices to 
be used are in good repair and free of 
tears and protrusions; 

(5) procedures for documenting the inter- 
vention which occurred to include, but 
not be limited to: 

(A) the rationale for the use of the inter- 



iB) 

IE] 
iEi 



vention which addresses attempts at 
and inadequacy of less restrictive 
intervention techniques; this shall 
contain a description of the specific 
behaviors justifying the use of seclu- 
sion, restraints, or isolation time out; 
notation of the frequency, intensity. 
and duration of the behavior and any 
precipitating circumstances contribut- 
ing to the onset of the behavior; 
description of the intervention and the 
date, time and duration of its use; 
estimated amount of additional time 
needed in seclusion, restraint or isola- 
tion time out; 



16} 



signature and title of the state facility 
employee responsible for the use of 
the intervention; and 
the time that the client was met with 
by the responsible professional; 

procedures for the notification of others 

to include: 



1088 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



(A) those to be notified as soon as possi- 
ble but no more than one working day 
after the behavior has been controlled 
to include: 

(i) the treatment/habilitation team, or 
its designee, after each use of the 
intervention; 

(ii) a designee of the State Facility 
Director; and 

(iii) the internal client advocate, in 
accordance with the provisions of 
G.S. 122C-53(g); and 

(B) notification in a timely fashion of the 
legally responsible person of a minor 
client or an incompetent adult client 
when such notification has been re- 
quested. 

(e) Seclusion, restraint and isolation time out 
shall not be employed as punishment or for the 
convenience of stafl^ or used m a manner that 
causes harm or undue physical or mental discom- 
fort or pain to the client. 

(f) Whenever a client is in seclusion, restraint or 
isolation time out for more than 24 continuous 
hours, the client's rights, as specified ]n G.S. 
122C-62, are restricted. The documentation 
requirements in this Rule shall satisfy the require- 
ments specified in G.S. 122C-62(e) for restriction 
of rights. 

(g) Whenever seclusion, restraint or isolation 
time out is used more than three times in a calen- 
dar month: 

(1) a pattern of behavior has developed and 
future emergencies can be reasonably 
predicted; and 

(2) dangerous behavior can no longer be 
considered unanticipated; and 

(3) emergency procedures shall be ad- 
dressed as a planned intervention in the 
treatment/habilitation plan. 

(h) In addition to the requirements in this Rule, 
additional safeguards as specified in Rule .0210 of 
this Section shall be initiated whenever: 

(1) a client exceeds spending 40 hours, or 
more than one episode of 24 or more 
continuous hours of time in emergency 
seclusion, restraint or isolation time out 
within a 30-day period; or 

(2) seclusion, restraint or isolation time out 
is: 

(A) used as a measure of therapeutic 
treatment as specified in G.S. 122C- 
60; and 

(B) limited to specific planned behavioral 
interventions designed for the extinc- 



tion of dangerous, 
undesirable behaviors. 



aggressive or 



{i} The written approval of the State Facility 
Director or designee shall be required when 
seclusion, restraint or isolation time out [s utilized 
for longer than 24 continuous hours. 

(j) Standing orders or PRN orders shall not be 
used to authorize the use of seclusion, restraint or 
isolation time out. 

(k) The client shall be removed from seclusion, 
restraint or isolation time out when: 



ill 



m 



the client no longer demonstrates the 
behavior which precipitated the seclu- 
sion, restraint or isolation time out; 
however. 



in no case shall the client remain in 
seclusion, restraint or isolation time out 
longer than an hour after gaining be- 
havioral control; and 
(3) if the client is unable to gain self-con- 
trol within the time frame specified in 
the authorization, a new authorization 
must be obtained. 
(1) Whenever seclusion, restraints, or isolation 
time out are used on an emergency basis prior to 
inclusion in the treatment/ habilitation plan, the 
following procedures shall be followed: 



ill 



12} 



£A} 



IB] 



A state facility employee authorized to 
administer emergency interventions may 
employ such procedures for up to 15 
minutes without further authorization. 
A qualified professional may authorize 
the continued use of seclusion, re- 
straints, or isolation time out for up to 
one hour from the initial employment of 
the intervention [f the qualified profes- 
sional: 
has experience and training in the use 
of seclusion, restraints, or isolation 
time out; and 

has been pnvileged to employ such 
interventions. 
(3) If a qualified professional is not imme- 
diately available to conduct a face-to- 
face assessment of tlie client, but after 
discussion with the state facility em- 
ployee, the qualified professional con- 
curs that the intervention is justified for 
longer than 15 minutes, then the quali- 
fied professional: 
(A) may verbally authorize the continua- 
tion of the intervention for up to one 
hour; 
£B) shall meet with and assess the client 
within one hour after authorizing the 



8:12 



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September 15, 1993 



1089 



PROPOSED RULES 



continued use of the intervention; and 
(C) shall immediately consult with the 
professional responsible for the 
client's treatment/habilitation plan, if 
the intervention needs to be continued 
for longer than one hour. 

(4) TTie responsible professional shall au- 
thorize the continued use of seclusion, 
restraints, or isolation time out for 
periods over one hour. 

(5) If the responsible professional is not 
immediately available to conduct a 
clinical assessment of the client, but 
after discussion with the qualified pro- 
fessional concurs that the intervention is 
justified for longer than one hour the 
responsible professional: 

(A) may verbally authorize the continua- 
tion of the intervention until an onsite 
assessment of the client can be made: 
however, 

(B) if such authorization cannot be ob- 
tained, the intervention shall be dis- 
continued. 

(6) If the responsible professional and the 
qualified professional are the same 
person, the documentation requirements 
of this rule can be done at the time of 
the documentation required by Subpara- 
graph .0206(d)(5) of this Section. 

(7) The responsible professional, or if the 
responsible professional is unavailable, 
the on-service or covering profession- 
al, shall meet with and assess the client 
within three hours after the client is 
first placed in seclusion, restraints, or 
isolation time out, and document in 
detail: 



(A) the reasons for continuing seclusion, 
restraints, or isolation time out; and 

(B) the client's response to the interven- 
tion. In addition, the responsible 
professional shall provide an evalua- 
tion of the episode and propose rec- 
ommendations regarding specific 
means for preventing future episodes. 
Clients who have been placed in 
seclusion, restraints, or isolation time 
out and released m less than three 
hours shall be examined by the re- 
sponsible professional who authorized 
the intervention no later than 24 hours 
after the episode. 

(8) Each incident shall be reviewed by the 
treatment team, which shall include 



possible alternative actions and specific 
means for preventing future episodes, 
(m) While the client is in seclusion, restraint or 
isolation time out, the following precautions shall 
be followed: 

(1 ) Whenever a client is in seclusion: 

(A) periodic observation of the client shall 
occur at least every 15 minutes, or 
more often as necessary, to assure the 
safety of the client. Observation may 
include direct line of sight or the use 
of video surveillance; 

(B) appropriate attention shall be paid to 
the provision of regular meals, bath- 
ing and the use of the toilet; and 

(C) such observation and attention shall 
be documented in the client record. 



(2) Whenever a client is in restraint, the 
facility must provide: 

(A) the degree of observation needed to 
assure the safety of those placed in 
restraint. The degree of observation 
needed fs determined at the time of 
application of tlie restraint after con- 
sideration of the following: 

£ij the type of restraint used; 

(ii) the individual patient situation; 

and 
(iii) the existence of any specific 
manufacturer's warning concern- 
ing the safe use of a particular 
product; 
Observation may include direct line of 
sight or the use of video surveillance. 
In no instance should observation be 
less frequent than at 15-minute inter- 
vals. 

(B) appropriate attention to the provision 
of regular meals, bathing and the use 
of the toilet; and 

(C) documentation of the above observa- 



tion and attention in the client record. 

(3) Whenever a client is in isolation time 

out there shall be: 

(A) a state facility employee in attendance 

with no other immediate responsibility 

than to monitor the client who is 



IB] 



placed in isolation time out; 
continuous observation and 



verbal 



interaction with the client when ap- 
propriate to prevent tension from 
escalating; and 
(C) documentation of such observation 
and verbal interaction in tlie client 
record. 



1090 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



(n) Reviews and reports on the use of seclusion, 
restraints, or isolation time out shall be conducted 
as follows: 

(1) the State Facility Director or designee 
shall review all uses of seclusion, re- 
straints, or isolation time out in a time- 
ly fashion and investigate unusual or 
possibly unwarranted patterns of utiliza- 
tion; and 

(2) each State Facility Director shall main- 
tain a log which includes the following 
information on each use of seclusion, 
restraints, or isolation time out: 

(A) name of the client; 

(B) name of the responsible professional: 

(C) date of each intervention; 

(D) time of each intervention; 

(E) duration of each intervention. 

(o) Nothing in this Rule shall be interpreted to 
prohibit the use of voluntary seclusion, restraints. 
or isolation time out at the client's request; howev- 
er, the procedures in Paragraphs (a) through (m) 
of this Rule shall apply. 

Statutory Authority G.S. 122C-51: 122C-53; 122C- 
57; 122C-60; 122C-62: 131E'67; 143B-147. 

SUBCHAPTER 14L - LICENSURE RULES 
FOR MENTAL HEALTH FACILITIES 

SECTION .0600 - RESIDENTIAL 

TREATMENT FOR CHILDREN AND 

ADOLESCENTS WHO ARE MENTALLY 

ILL 

,0602 CAPACITY 

{&) — Each facility shall s ervo no mor e than: 
^4^ nin e childr e n; or 



m- 



nin e adol e oo e nts. 



(b) Any facility curr e ntly lic e ns e d a i 3 a R e sid e n 
tial Tr e atment C e nter und e r this Section on th e 
e ff e ctiv e dat e of this Rule, and providing s e rvices 
to more than nin e childr e n or nin e adol e scents, 
may continu e to provid e services at no more than 
th e facility's lic e ns e capacity as of th e e ff e ctiv e 
date of this Rul e . 

(e) — At no time shall a R e sidential Treatm e nt 
C e nt e r serv e mor e than 2 4 childr e n or 2 4 adol e s 
cents. 

(a) Each facility shall serve no more than a total 
of J_2 children and adolescents, except as set forth 
in Paragraphs (b) and (c) of this Rule. 

(h) Any facility currently licensed as a Residen- 
tial Treatment Facility under this Section on the 
effective date of this Rule, and providing services 



to more than a total of J_2 children and adoles- 
cents, is exempt from the provision in Paragraph 
(a) of this Rule and may continue to provide 
services at no more than the facility's licensed 
capacity, providing that the capacity does not 
exceed 24. 

(c) Any Child Caring Institution which is cur- 
rently licensed by the Division of Social Services 
on the effective date of this Rule, may seek licen- 
sure as a Residential Treatment Facility as follows: 

(1) the capacity of each residential unit in 
the Residential Treatment Facility shall 
be limited to \2 children and adoles- 
cents; 

(2) each residential unit will be adminis- 
tered, staffed, and located to function 
separately from all other residential 
units in the facility; and 

(3) the overall capacity shall be limited to 
the current capacity of the institution at 
the time of licensure as a Residential 
Treatment Facility. 

(d) The two former Child Caring Institutions 
that are currently licensed as Residential Treatment 
Facilities under this Section on the effective date 
of this Rule shall be: 

(1) exempt from the capacity limit of 24; 
exempt from the provisions in Subpara- 
graphs (c)(1) and (2) of this Rule; and 
limited to the licensed capacity existing 
on July 1. 1993. 



t3) 



Statutory Authority G.S 122C-26; 143B-147. 

iSotice is hereby given in accordance with G.S. 
150B-21.2 that the Social Services' Commission 
intends to amend rules cited as 10 NCAC 42W 
.0001 and .0002. 

1 he proposed effective date of this action is 
December 1, 1993. 

1 he public hearing will be conducted at 10:00 
a.m. on October 19, 1993 at the Albemarle Build- 
ing, Conference Room 844, 325 North Salisbury 
Street. Raleigh, NC 

iXeason for Proposed Action: The current rules of 
the Social Services ' Commission regarding eligibil- 
ity criteria for the State Abortion Fund have been 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1091 



PROPOSED RULES 



preempted by recent legislation of the North 
Carolina General Assembly and must be immedi- 
ately amended. ("Current Operations Appropria- 
tions Act of 1993", Chapter 321, Senate Bill 27, 
Section 259.1 ratified July 9, 1993.) 

(comment Procedures: Comments may be pre- 
sented in writing anytime before or at the public 
hearing or orally at the hearing. Time limits for 
oral remarks may be imposed by the Commission 
Chairman. Any person may request copies of 
these rules by calling or writing to Special Assis- 
tant, Division of Social Services, 325 North Salis- 
bury Street, Raleigh, NC 27603, 919/733-3055. 

hiditor's Note: These Rules were filed as tempo- 
rary amendments effective August 13, 1993 for a 
period of 180 days or until the permanent rules 
become effective, whichever is sooner. 

CHAPTER 42 - INDIVIDUAL AND FAMILY 
SUPPORT 

SUBCHAPTER 42W - STATE ABORTION 
FUND 

.0001 NATURE AND SCOPE 

(a) The State Abortion Fund is a financial 
resource to pay for abortion procedures for North 
Carolina residents who moot Title XX eligibility 
criteria for health support services and specific 
eligibility criteria as established in Chapter 4 79, 
Section 93 of the 1985 Session Laws, need the 
procedure and who meet the eligibility criteria 
established in Chapter 321, Section 259.1 of the 
1993 Session Laws and the criteria in ^0 NCAC 
35E .0106 for Health Support Services including 
all subsequent amendments and editions. A copy 
of this Rule may be obtained from the Office of 
Administrative Hearings, Post Office Drawer 
27447, Raleigh, NC 27611-7447,(919)733-2678, 
at a cost of two dollars and fifty cents ($2.50) for 
up to ten pages and fifteen cents £$ .15) for each 
additional page at the time of adoption of this 
Rule. 

(b) fH The State Abortion Fund is administered 
by the Division of Social Services. 

^ TTie State Abortion Fund pays a maxJ 

mum rate of one hundred fifty dollars 
($150.00) for first trimester abortions and 
five hundred dollars ($500. (X)) for second 
trime s ter abortions. 

i%^ Abortions performed after the 135th day 



of gootation are not reimburoabl e under 
the State Abortion Fund. 

(c) (4) Only abortions performed in accordance 
with applicable state laws are reimbursable under 
the State Abortion Fund. 

Statutory Authority G.S. 14-45.1; 143B-153; 1985 
S.L., c. 479, s. 93: 1993 S.L. c. 321, s. 259. 

.0002 ELIGIBILITY 

(a) State Abortion Funds are administered 
uniformly in every political subdivision of the 
state. Applications are made to county depart- 
ments of social services. A county other than the 
client's county of residence may authorize State 
Abortion Funds for individuals who do not want to 
apply for services in their own counties for reasons 
of confidentiality. 

(b) Applicants must be residents of North 
Carolina and meet the eligibility criteria estab- 
lished in Chapter 321, Section 259.1a of the 1993 
Session Laws and the criteria in \0 NCAC 35E 
.0106 for Health Support Services including all 
subsequent amendments and editions. A copy of 
this Rule may be obtained from the Office of 
Administrative Hearings, Post Office Drawer 
27447, Raleigh, NC 27611-7447,(919)733-2678. 
at a cost of two dollars and fifty cents ($2.50) for 
up to ten pages and fifteen cents {^ .15) for each 
additional page at the time of adoption of this 
Rule. 

fe) — Applicants who m ee t the sp e cific e ligibility 
crit e ria — establish e d — m — the — 1985 — Session — Laws 
Chapter 4 79, S e ction 93, and who are r e cipients of 
aid to famili e s with depend e nt children, or who are 
r e c e iving health support services in conjunction 
with prot e ctive s e rvices for children or disabled 
adults, or whos e income is four thousand, two 
hundred and tw e nty six dollars ($ 4 ,226.00) per 
year for a on e p e r s on household (which is 50 
percent of the state's establish e d income for social 
servic e s) will b e e ligible for the State Abortion 
Fund. 

(d) Marital status and ag e will not affect eligibil 
ity for the Stat e Abortion Fund except as opooified 
in 19 8 5 Session Law s Chapter 4 79, S e ction 93. 

Statutory Authority G.S 14-45.1; 143B-153; 1985 
S.L. c. 479, s. 93; 1993 S.L. c. 321, s. 259.1. 

TITLE 11 - DEPARTMENT 
OF INSURANCE 

iSotice is hereby given in accordance with G.S. 



1092 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



] 508-21. 2 that the N.C. Department of Insurance 
intends to adopt rule cited as 11 NCAC IIH 
.0011. 

1 he proposed effective date of this action is 
December 1. 1993. 

1 he public hearing will be conducted at 10:00 
a.m. on September 30, 1993 at the Dobbs Build- 
ing, 3rd Floor Hearing Room, 430 North Salisbury 
Street, Raleigh. NC 27611. 

Jxeason for Proposed Action: Establishes a 
financial review process in determining if Continu- 
ing Care Facilities are insolvent. 

(comment Procedures: Written comments may be 
sent to Bill Darden at PO. Box 26387, Raleigh. 
NC 27611. Oral presentations may be made at 
the public hearing. Anyone having questions 
should call Bill Darden at (919) 733-5060 or Ellen 
Sprenkel at (919) 733-4529. 



CHAPTER 11 



FINANCIAL EVALUATION 
DIVISION 



SUBCHAPTER IIH - CONTINUING CARE 
FACILITIES 

.0011 INSOLVENCY OR HAZARDOUS 
FINANCIAL CONDITION 

(a) The Commissioner may deem a provider or 
facility that has a negative fund balance to be 
insolvent. A negative fund balance is a financial 
position in which provider's or facility's assets do 
not exceed its liabilities as required under general- 
ly accepted accounting principles. 

(b) The Commissioner may also deem a provid- 
er or facility to be in imminent danger of becom- 
ing insolvent if any of the following hazardous 
financial condition standards or factors are applica- 
ble or present: 

(1) There are adverse findings or condi- 
tions reported in the provider's or 
facility's financial statements. 

£2} The current or projected ratios of total 
assets, including required reserve lev- 
els, to total liabilities indicate an im- 
pairment or a deterioration of the pro- 
vider's or facility's operations or equi- 
ty; or demonstrate a trend that could 
lead to an impairment or a deterioration 



of the provider's or facility's opera- 
tions, working capifal, or equity. 

(3) The current or projected ratios of cur- 
rent assets to current liabilities indicate 
an impairment or a deterioration of the 
provider's or facility's operations, 
working capital, or equity; or demon- 
strate a trend that could lead to an 
impairment or a deterioration of the 
provider's or facility's operations, 
working capital, or equity. 

(4) The provider or facility ]s unable to 
perform normal daily activities and 
meet its obligations as they become 
due, considering the provider's or 
facility's current or projected cash flow 
and liquidity position. 

£5} The provider's or facility's operating 
losses for the past year or projected 
operating losses are of such magnitude 
as to jeopardize normal daily activities 
or continued provider or facility opera- 
tions. 

(6) The insolvency of an affiliated provider 
or facility or other affiliated person 
results in legal liability of the provider 
or facility for payments and expenses of 
such magnitude as to jeopardize the 
provider's or facility's ability to meet 
its obligations as they become due, 
without substantial disposition of assets 
outside the ordinary course of business, 
any restructuring of debt, or externally 
forced revisions of its operations. 

(7) The provider or facility has receivables 
that are more than 90 days old. 

(8) The insolvency is not temporary and 
the provider or facility can not demon- 
strate that the insolvency is materially 
reduced or eliminated over the next 
fiscal quarter. 

(9) There is an adverse effect on the pro- 
vider or facility of reporting entrance 
fees as deferred revenues, with consid- 
eration given to all reporting require- 
ments required under generally accept- 
ed accounting principles and the ulti- 
mate net income component of those 
revenues. 

(10) A stert-up provider or facility or any 
operational provider or facility under- 
going plant expansion or refinancing of 
its debt has a financial condition as a 
result of such action that could other- 
wise seriously jeopardize present or 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1093 



PROPOSED RULES 



future operations, 
(c) The provider or facility shall prepare a plan 
to address and correct any condition that has led to 
a determination of insolvency or imminent danger 
of insolvency by the Commissioner. The plan 
must be presented to the Commissioner within 90 
days after the date of the insolvency determination. 
If the plan to correct the condition is disapproved 
by the Commissioner, the plan does not correct the 
condition leading to the Commissioner's determi- 
nation of insolvency, or the provider's or facility's 
hazardous condition is such that it cannot be 
significantly corrected or eliminated by the end of 
the next fiscal quarter, the Commissioner may then 
proceed under G.S. 58-64-10 or G.S. 58-64-45. 

Statutory Authority G. S. 58-2-40: 58-64-10: 58-64- 
45: 58-64-65. 

jyiotice is hereby given in accordance with G.S. 
150B-21.2 that the N.C. Department of Insurance 
intends to amend rule cited as 11 NCAC 12 . 1004 
and adopt rule cited as 11 NCAC 12 .1022. 

1 he proposed effective date of this action is 
December 1. 1993. 

1 he public hearing will be conducted at 10:00 
a.m. on September 30, 1993 at the Dobbs Build- 
ing, 3rd Floor Hearing Room, 430 North Salisbury 
Street, Raleigh, NC 27611. 

Ixeason for Proposed Action: To comply with 
standards established by the National Association 
of Insurance Conunissioners through the Long- 
Term Care Mode! Act as adopted January 1993. 

K^omment Procedures: Written comments may be 
sent to T. N. Shackelford at PO. Box 26387. 
Raleigh. NC 27611. Oral presentations may be 
made at the public hearing. Anyone having ques- 
tions should call T N. Shackelford at (919) 733- 
5060 or Ellen Sprenkel at (919) 733-4529. 

CHAPTER 12 - LIFE .\ND HEALTH 
DI'VTSION 

SECTION .1000 - LONG-TERM CARE 
INSURANCE 



.1004 POLICi PRACTICES AND 
PROVISIONS 

(a) The terms "guaranteed renewable" or "non- 
cancellable" may not be used in any individual 
policy without further explanatory language in 
accordance with the disclosure requirements of 1 1 
NCAC 12 AQQ§ .1006. No such policy issued to 
an individual shall contain renewal provisions 
other than "guarante<;d renewable" or "noncancel- 
lable" . 

(b) The term "guaranteed renewable" may be 
used only when the insured has the right to contin- 
ue the policy in force by timely payments of 
premiums; during which period the insurer has no 
unilateral right to make any change in any provi- 
sion of the policy while the policy is in force and 
can not refuse to renew: Provided that rates may 
be revised by the insurer on a class basis. 

(c) The word "noncancellable" may be used 
only when the insured has the right to continue the 
policy in force by timely payments of premiums; 
during which period the insurer has no right to 
unilaterally make any change in any provision of 
the policy or in the premium rate. 

(d) No policy may limit or exclude coverage by 
type of illness, treatment, medical condition, or 
accident, except as follows: 

(1) preexisting conditions as specified in 
G.S. 58-55-30; 

(2) mental or nerv'ous disorders, except for 
Alzheimer's Disease; 

(3) alcoholism and drug addiction; 

(4) illness, treatment, or medical condition 
arising out of: 

(A) war or act of war (whether declared 
or undeclared); 

(B) participation in a felony, riot, or 
insurrection; 

(C) ser\ice in the armed forces or units 
auxiliary thereto; 

(D) suicide, attempted suicide, or inten- 
tionally self-inflicted injury; or 

(E) a\iation activity as a nonfare-paying 
passenger; 

(5) treatment provided in a government 
facility (unless otherwise required by 
law); services for which benefits are 
available under Medicare, under any 
other governmental program (except 
Medicaid), or under any state or federal 
workers' compensation, employer's 
liability, or occupational disease law; 
ser\'ices provided by a member of the 
insured's immediate family; and servic- 
es for which no charge is normally 



1094 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



made in the absence of insurance; 

(6) exclusions and limitations for payment 
for services provided outside the United 
States; and 

(7) legitimate variations in benefit levels to 
reflect differences in provider rates. 

(e) Termination of a policy shall be without 
prejudice to any benefits payable for institutional- 
ization if the institutionalization began while the 
policy was in force and continues without interrup- 
tion after termination. Such extension of benefits 
beyond the period during which the policy was in 
force may be limited to the duration of the benefit 
period, if any, or to payment of the maximum 
benefits; and may be subject to any policy waiting 
period and all other applicable provisions of the 
policy. 

Statutory Authority G.S. 58-2-40(1); 58-55-20(a). 

.1022 PROTECTION AGAINST 
UNINTENTIONAL LAPSE 

(a) No individual policy shall be issued until the 
insurer has received from the applicant either a 
written designation of at least one person, in 
addition to the applicant, who is to receive notice 
of lapse or termination of the policy for nonpay- 
ment of premium; or a written waiver dated and 
signed by the applicant electing not to designate 
additional persons to receive notice. Every appli- 
cant has the right to so designate at least one 
person. Designation does not constitute acceptance 
of any liability on the part of the designated person 
or persons for services provided to the insured. 
TTie form used for the designation must provide 
space clearly designated for listing at least one 
person. The designation shall include each 
person's full name and home address. If an 
applicant elects not to designate any person, a 
written, signed waiver shall state: 

"Protection against unintended 
lapse. I understand that I have 
the right to designate at least one 
person other than myself to re- 
ceive notice of lapse or termina- 
tion of this long-term care insur- 
ance policy for nonpayment of 
premium. I understand that 
notice will not be given until 
thirty (30) days after a premium 
is due and unpaid. I elect NOT 
to designate any person to receive 
such notice. " 

The insurer shall notify the insured of the right to 



change this written designation no less often than 
once every two years. 

(b) When a policyholder pays premium for a 
policy through a payroll or pension deduction plan, 
the requirements contained in Paragraph (a) of this 
Rule need not be met until 60 days after the 
policyholder is no longer on such a payment plan. 
The a pplication or enrollment form for such 
policies shall clearly indicate the payment plan 
selected by the a pplicant. 

("c) No individual policy shall lapse or be termi- 
nated for nonpayment of premium unless the 
insurer, at least 30 days before the effective date 
of the lapse or termination, has given notice to the 
insured and to any person or persons designated 
under Paragraph (a) of this Rule, at the addresses 
provided by the insured. Notice shall be given by 
first class United States mail, postage prepaid; and 
notice may not be given until 30 days after a 
premium is due and unpaid. Notice shall be 
deemed to have been given as of five days after 
the date of mailing. 

(d) In addition to the requirement in Paragraph 
(a) of this Rule, each policy shall provide for 
reinstatement of coverage if the insurer is fur- 
nished proof of cognitive impairment or the loss of 
functional capacity of tlie insured. This option is 
available to the insured if requested within five 
months after lapse or termination; and the insurer 
may require payment of past due premium before 
reinstatement, where a ppropriate. The standard of 
proof of cognitive impairment or loss of functional 
capacity shall not be more stringent than the 
benefit eligibility criteria on cognitive impairment 
or the loss of functional capacity, if any, contained 
in the policy. 

Statutory Authority G.S. 58-2-40(1); 58-55-30(a). 

I\otice is hereby given in accordance with G.S. 
150B-21 .2 that the N. C. Department of Insurance 
intends to amend rules cited as 11 NCAC 13 .0318 
and .0319. 

1 he proposed effective date of this action is 
December 1, 1993. 

1 he public hearing will be conducted at 10:00 
a.m. on September 30, 1993 at the Dobbs Build- 
ing, 3rd Floor Hearing Room, 430 N. Salisbury 
Street, Raleigh, NC 27611. 



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1095 



PROPOSED RULES 



Mxeason for Proposed Action: lb clarify language 
in these rules. 

(comment Procedures: Written comments may be 
sent to Fred Mohn at P.O. Box 26387, Raleigh. 
NC 27611. Oral presentations may be made at the 
public hearing. Artyone having questions should 
call Fred Mohn at (919) 733-2200 or Ellen 
Sprenkel at (919) 733-4529. 

CHAPTER 13 - SPECIAL SERVICES 
DIVISION 

SECTION .0300 - INSURANCE PREMIUM 
FINANCE COMPANIES 

.0318 NOTICE OF CANCELLATION 

The request for caDCcUation notice notice of 
cancellation as described in General Statute 
58-35-85(2) shall be signed by the owner or an 
officer of the premium finance company (the 
owner or officer's facsimile signature may be 
used), shall have in bold print at its top the word- 
ing "Request for Cancellation Notice" "Notice of 
Cancellation" and shall include the name and 
address of the insured; the name and address of 
the insurance company; the name and address of 
the premium finance company; the insurance 
company policy number; a certification that the 
ten-days notice of intent to cancel has been fur- 
nished to the insured; the authority under which 
the policy is to be cancelled; the date the request 
for cancellation notice notice of cancellation is 
mailed to the insured and to the insurance compa- 
ny; the effective date of cancellation; a notice 
stating, "If automobile liability insurance is includ- 
ed, you are cautioned that financial responsibility 
is required to be maintained continuously through- 
out the registration period and that operation of a 
motor vehicle without maintaining such financial 
responsibility is a misdemeanor, the penalty for 
which is loss of registration plate, and fine or 
imprisonment, in accordance with the motor 
vehicle laws of the State of North Carolina as they 
may be amended from time to time"; and all other 
pertinent information. 

Statutory Authority' G.S. 58-2-40; 58-35-85(2). 

.0319 EFFECTIVE DATE OF 
CANCELLATION 

When an insurance premium finance company 
cancels an insurance policy by using a power of 



attorney signed by the insured, the effective date 
of cancellation as stated in the r e qu e st for oano e lla 
tion notice notice of cancellation shall be no earlier 
than the date the request for cancellation notice is 
mailed to the insurance company. 

Statutory Authority G.S. 58-2-40; 58-35-85(2). 

TITLE 12 - DEPARTMENT 
OF JUSTICE 

iSotice is hereby given in accordance with G.S. 
150B-21.2 that the North Carolina Department of 
Justice intends to adopt rule cited as 12 NCAC 1 
.0106 

1 he proposed effective date of this action is 
December 1. 1993. 

1 he public hearing will be conducted at 10:00 
a.m. on October 4, 1993 at the N. C. Department 
of Justice, Olivia Raney Building, 1st Floor Con- 
ference Room, Raleigh, NC 27602. 

Keason for Proposed Action: To implement 
procedures for filing grievance under the Ameri- 
cans with Disabilities Act. 

i^omment Procedures: Interested persons may 
present their views either orally or in writing at 
the hearing. In addition, the record of hearing 
will be open for receipt of written comments from 
September 15, 1993 through October 15, 1993. 
Such written comments must be delivered or mailed 
to Melissa L. Trippe, Rulemaking Coordinator, 
104 Fayetteville Street Mall, P.O. Box 629. Ra- 
leigh. NC 27602. 

CHAPTER 1 - DEPARTMENTAL RULES 

SECTION .0100 - GENERAL PROVISIONS 

.0106 ADA DISPUTE RESOLUTION 
PROCEDURE 

(a) The North Carolina Department of Justice 
has established a grievance procedure to provide 
for prompt and equitable resolution of complaints 
alleging any action prohibited by the U.S. Depart- 
ment of Justice regulations implementing Title II 
of the Americans with Disabilities Act. Title II 
states in part that "no otherwise qualified individu- 
al with a disability shall, solely by reasons of the 



1096 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



) 



£2} 



> 



disability, be excluded from the participation in. be 
denied the benefits of, or be subjected to discrimi- 
nation" in programs or activities sponsored by a 
public entity. 

(h) Individuals seeking to initiate a grievance 
against the Department under Title II may initiate 
such grievance by following the steps below: 

(1) Step L. A complaint shall be filed in 
writing or orally, contain the name and 
address of the person filing itj^ and 
contain a brief description of the al- 
leged violation of the regulations. It 
shall be filed within 30 days after the 
complainant becomes aware of the 
alleged violation and must be submitted 
to: 
Charlotte W. Clark, ADA Coordinator 
North Carolina Department of Justice 

P.O. Box 629 
Raleigh, North Carolina 27602-0629 
(919)733-5837 
Step 2^ An investigation, as may be 
appropriate, shall follow a filing of the 
complaint and shall be conducted by the 
ADA Coordinator. The investigation 
will be thorough, and all interested 
parties, and their representatives if any, 
shall have an opportunity to submit 
evidence relevant to the complaint. If 
the complainant fails to comply with a 
request for information from the ADA 
Coordinator, he may be deemed to have 
abandoned his complaint. 
Step 3^ A written determination of the 
validity of the complaint, and a descrip- 
tion of the resolution if any, shall be 
issued by the ADA Coordinator with a 
copy to the complainant mailed via 
certified mail, return receipt requested, 
to the complainant's address of record 
no later than fifteen working days after 
the filing, or the complainant will be 
informed in writing of the reasons for 
delay and advised as to when a determi- 
nation may be expected. Should the 
complainant have a known disability 
that renders a different form of commu- 
nication necessary, the ADA Coordina- 
tor will make reasonable efforts to 
efFectively communicate her determina- 
tion. 

Step 4^ The complainant may request 
a reconsideration of the case in instanc- 
es of dissatisfaction with the resolution, 
within fifteen days of receipt of the 



13} 



(41 



written determination. The request 
shall be made to the ADA Coordinator. 
The ADA Coordinator shall forward the 
request to the North Carolina Depart- 
ment of Justice Personnel Qflicer. The 
Personnel Officer shall appoint a Com- 
mittee consisting of at least three De- 
partmental employees including the 
individual ultimately selected by the 
other committee members to be the 
Chair of the Committee. Selected 
employees must agree to serve before 
they will be placed on the Committee. 
Employees serving on a Committee 
shall inform the Departmental Person- 
nel Officer of any conflict of interest in 
their serving on a Committee reviewing 
a particular complainant's case. The 
Committee shall review the ADA 
Coordinator's determination and 
respond to the complainant no later than 
fifteen working days after the 
Committee is appointed. Alternatively, 
the complainant shall be informed, in 
writing, of the reasons for delay and 
advised as to when a determination may 
be expected. Should the complainant 
have a known disability that renders a 
different form of communication 
necessary, the Committee Chair will 
make reasonable eff'orts to effectively 
communicate the Committee's 
determination. If the complainant fails 
to comply with a request for 
information from the Committee, than 
he may be deemed to have abandoned 



his complaint. 
(5) Step 5^ The Committee's determination 
shall be simultaneously submitted to the 
Attorney General as a written report 
containing a recommended course of 
action. The Attorney General or his 
designated agent shall review the Com- 
mittee's determination and recommen- 
dations. The Attorney General may 
secure additional information that he 
deems necessary to render his decision. 
This may involve meeting with the 



parties. If the complainant fails to 
comply with a request for information 
from the Attorney General, he may be 
deemed to have abandoned his com- 
plaint. The Attorney General ma 



adopt the Committee's recommendation 
in whole or in part or may choose any 



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September 15, 1993 



1097 



PROPOSED RULES 



other course of action that he deems 
appropriate. The Attorney General's 
decision shall constitute the final De- 
partmental decision. It shall be in 
writing and mailed via certified mail, 
return receipt requested. to the 
complainant's address of record. 
Should the complainant have a known 
disability that renders a different form 
of communication necessary. the 
Department shall make reasonable 
efl'orts to effectively communicate its 
determination. The final Departmental 
decision shall be communicated to the 
complainant within 30 calendar days 
from the date the Committee's report is 
received in the Attorney General's 
office. If more time is needed by the 
Attorney General the complainant shall 
be notified. 

(c) A complainant also has the right during this 
process to pursue other remedies, such as filing an 
ADA complaint with the responsible federal 
agency. In addition, the complainant may pursue 
such remedies or court action if he continues to be 
dissatisfied after step 5 in Subparagraph (a)(5) of 
this Rule. 

(d) Tlie ADA Coordinator shall maintain the 
files and records of the North Carolina Department 
of Justice relating to the complaints filed for a 
period of three years after the final Departmental 
decision. 

Authority G.S. 114-1: 114-1.1:28 C.F.R. 35.107. 

TITLE ISA - DEPARTMENT OF 

ENVIRONMENT, HEALTH, AND 

NATURAL RESOURCES 

iSotice is hereby given in accordance with G.S. 
150B-21.2 that EHNR - Commission for Health 
Services intends to adopt rules cited as ISA NCAC 
13B .1701 - .1710. 

1 he proposed effective date of this action is 
Januan,' 4, 1994. 



MXeason for Proposed Action: These Rules estab- 
lish requirements for siting, design, construction, 
operation and closure of coal combustion 
by-product structural fill projects and its other 
uses. 

i^omment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P. O. Box 629, 
Raleigh, NC 27602-0629. All written comments 
must be received by October 20, 1993. Persons 
who wish to speak at the hearing should contact 
John P Barkley at (919)733-4618. Persons who 
call in advance of the hearing will be given 
priority' on the speaker's list. Oral presentation 
lengths may be limited depending on the number of 
people that msh to speak at the public hearing. 
Only persons who have made comments at a public 
hearing or who have submitted written comments 
will be allowed to speak at the Commission 
meeting. Comments made at the Commission 
meeting must either clarify previous comments or 
proposed changes from staff pursuant to comments 
made during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS. GROUPS, BUSINESSES, 
ASSOCIATIONS. INSTITUTIONS OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS. WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED RULES. THE 
COMMISSION MAY MAKE CHANGES TO THE 
RULES AT THE COMMISSION MEETING IF THE 
CHANGES COMPLY WITH G.S 150B-21.2(f). 

CHAPTER 13 
SOLID WASTE MANAGEMENT 

SUBCHAPTER 13B - SOLID WASTE 
MANAGEMENT 



1 he public hearing will be conducted at 10:00 
a.m. on October 15, 1993 at the Groundfloor 
Hearing Room. Archdale Building, 512 N. Salis- 
bury Street, Raleigh. N.C 



SECTION .1700 - REQUIREMENTS FOR 

BENEFICIAL USE OF COAL 

COMBUSTION BY-PRODUCTS 

J 701 DEFINITIONS 

The following definitions shall apply throughout 



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PROPOSED RULES 



this Section: 

(1) "Beneficial and beneficial use" means 
projects promoting public health and 
environmental protection, ofl^ering equiv- 
alent success relative to other alterna- 
tives, and preserving natural resources. 

(2) "Coal combustion by-products" means 
residuals, including fly ash, bottom ash, 
boiler slag and flue gas desulfiirization 
residue produced by coal fired electrical 
or steam generation units. 

(3) "Jurisdictional wetland" means those 
areas that meet the criteria established by 
the United States Environmental Protec- 
tion Agency for delineating wetlands and 
are considered by the Division to be 
waters of the United States. 

(4) "Structural fill" means an engineered fill 
with a projected beneficial end use con- 
structed using coal combustion by-prod- 
ucts properly placed and compacted. 

- £5} "Use or reuse of coal combustion by- 
products" means the procedure whereby 
coal combustion by-products are directly 
used as follows: 
(a) As an ingredient in an industrial pro- 
cess to make a product, unless distinct 
components of the coal combustion by- 
products are recovered as separate end 
products; or 
(h) In a function or application as an efiFec- 
tive substitute for a commercial product 
or natural resource. 

Statutory Authority G. S. 130A-294. 

.1702 GENERAL PROVISIONS FOR 

STRUCTURAL FILL FACILITIES 

The provisions of this Section shall app ly to the 
siting, design, construction, operation, closure and 
recordation of projects which utilize coal combus- 
tion by-products as structural fill material or as 
specified in Item (4) of Rule .1708 of this Section 
and shall apply to structural fills other than those 
which received written approval from the Division 
prior to the eff'ective date of this Section. A solid 
waste management permit is not required for coal 
combustion by-products structural fills which meet 
the requirements listed in this Section. 

Statutory Authority G.S. 130A-294. 

.1703 NOTIFICATION FOR STRUCTURAL 
FILL FACILITIES 

(a) A minimum of 30 days before using coal 



combustion by-products m structural fill projects, 
the person proposing the use shall submit a written 
notice to the Division. The notice shall contain, at 
a minimum: 

(1) A description of the nature, purpose 
and location of the project, including 
the name of the United States Geologi- 
cal Survey seven and one-half minute 
map on which the project is located and 
a Department of Transportation map or 
an eight and one-half by 1 1 mch topo- 
graphic map showing the project. 
The estimated start and completion 
dates for the project. 
An estimate of the 



12} 
£3} 

14} 



15} 



_ volume of coal 

combustion by-products to be used for 
the project. 

A Toxicity Characteristic Leaching 
Procedure (TCLP) analysis from a 
representative sample of each different 
coal combustion by-product source to 
be used in the project. The TCLP 
analysis shall be conducted and certified 
by the generator to be representative of 
each coal combustion by-product source 
used in the project. A TCLP analysis 
shall be conducted at least annually. A 
minimum analysis shall include: arsen- 
ic, barium, cadmium, lead, chromium, 
mercury, selenium and silver. 
A signed and dated statement by the 
owner(s) of the land on which the 
structural fill i^ to be placed, acknowl- 
edging and consenting to the use of coal 
combustion by-products as structural fill 
and agreeing to record the fill in accor- 
dance with Rule .1707 of this Section. 
The notification shall include: 
Name of coal combustion by-products 
generator; 

Physical location of flie generating 
facility: 

Address of generator; 
Name of contact for generator; 
Telephone number of generator; and 
Changes that occur will require subse- 
quent notification of the Division of 
Solid Waste Management, 
(b) In addition to the notification requirements 
under Paragraph (a) of this Rule, at least 30 days 
before using coal combustion by-products as a 
structural fill in projects with a volume of more 
than 10,000 cubic yards, the person proposing the 
use shall submit a written notice to the Division 
containing construction plans for the structural fill 



16} 



£A} 

im 

ID} 
IE} 
IF} 



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September 15, 1993 



1099 



PROPOSED RULES 



facility, including a stability analysis when neces- 
sary, which shall be prepared, signed and sealed 
by a registered professional engineer in accordance 
with sound engineering practices. The Department 
of Transportation js not required to submit con- 
struction plans with the written notice. The 
Department of Transportation shall maintain a 
complete set of construction plans and shall notify 
the Division where the construction plans are 
located. 

Statutory Authority G. S. 130A-294. 

.1704 SITING FOR STRUCTURAL FILL 
FACILITIES 

(a) Coal combustion by-products used as a 
structural fill shall not be placed: 

(1) Within 50 horizontal feet of a jurisdic- 
tional wetland or from the top of the 
bank of any regularly flowing water 
body or stream; 

Within two feet of the seasonal high 
ground-water table: 

Within 100 horizontal feet of any 
source of drinking water, such as a 
well, spring or other groundwater 



(2) 
Oi 

14} 



source of drinking water; 



Within an area subject to a one-hundred 
year flood, unless it can be demonstrat- 
ed to the Division that the facility will 
be protected from inundation, and 
washout, and the flow of water is not 
restricted and the storage volume of the 
flood plain will not be significantly 
reduced; 

(5) Within 25 feet of any property bound- 
ary; and 

(6) Within 25 feet of a bedrock outcrop, 
(b) The Division and the Department of Trans- 
portation may agree on specific structural fill siting 
criteria that may be used on Department of Trans- 
portation projects. 

Statutory Authority G. S. 130A-294. 

.1705 DESIGN, CONSTRUCTION, AND 
OPERATION FOR STRUCTURAL 
FILL FACILITIES 

(a) The structural fill facility must be designed, 
constructed, operated, closed, and maintained in 
such a manner as to minimize the potential for 
harmful release of constituents of coal combustion 
by-products to the environment or create a nui- 
sance to the public. 

£bj Coal combustion by-products shall be col- 



lected and transported in a manner that will pre- 
vent nuisances and hazards to public health and 
safety. Coal combustion by-products shall be 
moisture conditioned, as necessary, and transport- 
ed in covered trucks to prevent dusting. 

(c) Coal combustion by-products shall be placed 
uniformly and compacted in lifts not exceeding one 
foot in thickness and shall be compacted to stan- 
dards, including in-situ density, compaction efFort 
and relative density, specified by a registered 
professional engineer for a specific end use pur- 
pose. 

(d) Equipment shall be provided which is capa- 
ble of placing and compacting the coal combustion 
by-products and handling the earthwork required 
during the periods that coal combustion by-prod- 
ucts are received at the fifl area. 

(e) The coal combustion by-product structural 
fill facility shall be efl'ectively maintained and 
operated as a non-discharge system to prevent 
discharge to surface water resulting from the 
operation of the facility. 

(f) The coal combustion by-product structural 
fill facility shall be effectively maintained and 
operated to ensure no violations of ground water 
standards, 15A NCAC 2L. 

(g) Surface waters resulting from precipitation 
shall be diverted away from the active coal com- 
bustion by-product placement area during filling 
and construction activity. 

Q[\) Site development shall comply with the 
North Carolina Sedimentation Pollution Control 
Act of 1973, as amended. 

(i) The structural fill project must be operated 
with sufficient dust control measures to minimize 
airborne emissions and to prevent dust from 
creating a nuisance or safety hazard and must not 
violate applicable air quality regulations. 

ijj AU structural fills shall be covered with a 
minimum of VI inches compacted earth, and an 
additional surface six inches of soil capable of 
supporting the growth of suitable vegetation. 

(k) Compliance with these standards does not 
insulate any of the owners or operators from 
claims for damages to surface waters, ground- 
water or air resulting from the operation of the 
structural fill facility. If the facility fails to com- 
ply with the requirements of this Section, the 
constructor, generator, owner or operator shall 
notify the Division and shall take such immediate 
corrective action as may be required by the De- 
partment. 

(1) Coal combustion by-products utilized on an 
exterior slope of a structural fill shall not be 
placed with a slope greater than 3.0 horizontal to 



1100 



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PROPOSED RULES 



1.0 vertical . 

(m) The Division and the Department of Trans- 
portation may agree on specific design, construc- 
tion, and operation criteria that may apply to the 
Department of Transportation projects. 

Statutory Authority G. S. 130A-294. 

.1706 CLOSURE OF STRUCTURAL FILL 
FACILITIES 

(a) No later than 30 working days or 60 calen- 
dar days, whichever is less after coal combustion 
by-product placement has ceased, the final cover 
shall be applied over the coal combustion by- 
product placement area. 

(b) The final surface of the structural fill shall 
be graded and provided with drainage systems 
that: 

(1) Minimize erosion of cover materials; 
and 

(2) Promote drainage of area precipitation, 
minimize infiltration and prevent pond- 
ing of surface water on the structural 
fill. 

(c) Other erosion control measures, such as 
temporary mulching, seeding, or silt barriers shall 
be installed to ensure no visible coal combustion 
by-product migration to adjacent properties until 
the beneficial end use of the project \s realized. 

(d) The constructor or operator shall submit a 
certification to the Division signed and sealed by 
a registered professional engineer or signed by the 
Secretary of the Department of Transportation or 
his designee certifying that all requirements in the 
Rules of this Section have been met. The report 
shall be submitted within 30 days of a pplication of 
the final cover. 

(e) The Division and the Department of Trans- 
portation shall agree on specific closure criteria 
that a pply to Department of Transportation pro- 
jects. 

Statutory Authority G.S. 130A-294. 

A1(S1 RECORDATION OF STRUCTURAL 
FILL FACILITIES 

(a) The owners of land where coal combustion 
by-products have been utilized in volumes of more 
than 1,000 cubic yards shall file a statement of the 
volume and locations of the coal combustion by- 
products with the Register of Deeds in the county 
or counties where the property is located. The 
statement shall identify the parcel of land accord- 
ing to the complete legal description on the record- 
ed deed, either by metes and bounds, or by refer- 



ence to a recorded plat map. The statement shall 
be signed and acknowledged by the landowners(s) 
in the form prescribed by G.S. 47-38 through 47- 

(b) Recordation shall be required within 90 days 
after completion of coal combustion by-product fill 
project. 

(c) The Register of Deeds in accordance with 
G.S. 161-14 shall record the notarized statement 
and index it in the Grantor Index under the name 
of the owner(s) of the land. TTie original notorized 
statement with the Register's seal and the date, 
book and page number of recording shall be 
returned to the Division after recording. 

(d) When property with more than 1,000 cubic 
yards of coal combustion by-products ]s sold, 
leased, conveyed or transferred in any manner, the 
deed or other instrument of transfer shall contein 
in the description section in no smaller type than 
used in the body of the deed or instrument a 
stotement that coal combustion by-products have 
been used as fill material on the property. 

Statutory Authority G.S. 130A-294. 

.1708 OTHER USES FOR COAL 

COMBUSTION BY-PRODUCTS 

Coal combustion by-products may be beneficially 
used on one or more of the following applications 
or when handled, processed, transported or stock- 
piled for such beneficial use applications and do 
not require a solid waste permit provided the uses 
are consistent with the requirements identified 
below: 

Coal combustion by-products used as soil 
nutrient additives or other agricultural 
purposes under the authority of the North 
Carolina Department of Agriculture; 
Coal combustion bottom ash or boiler 



m 



111 



13) 



(4] 



slag used as a traction control material or 
road surface material if the use is ap- 
proved by the North Carolina Department 
of Transportation; 

Coal combustion by-products used as 
material in the manufacturing of another 
product, such as concrete products, light- 
weight aggregate, roofing materials, 
plastics, paint, flowable fill and roller 
compacted concrete or as a substitute for 
a product or material resource, including 
but not limited to, blasting grit, roofing 
granules, filter cloth precoat for sludge 
dewatering and pipe bedding; 
Coal combustion by-products used as a 
structural fill for the base, sub-base. 



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1101 



PROPOSED RULES 



under a structure or the footprint of a 
paved road, a parking lot, sidewalk, 
walkway or similar structure: 

(5) Coal combustion by-products used for the 
extraction or recovery of materials and 
compounds contained within the coal 
combustion by-products. Residuals from 
the processing operations shall remain 
solid waste and be subject to this Section 
and Section . 1600 of this Subchapter; and 

(6) Coal combustion by-products processed 
with a cementitious binder to produce a 
stabilized structural fill product which is 
spread and compacted for the construc- 
tion of a project with a planned end use. 

Statutory Authority G.S. 130A-294. 

.1709 STORAGE AND CONTAINMENT OF 
COAL COMBUSTION BY-PRODUCTS 

(a) Coal combustion by-products may not be 
stored or speculatively accumulated at the immedi- 
ate area where they will be gut to beneficial use 
for a longer period of time than necessary to 
complete the project. Coal combustion by-prod- 
ucts are not being speculatively accumulated when 
a minimum of 75 percent of the coal combustion 
by-products are removed from the facility and 
beneficially used annually. 

(b) Compliance with this Section does not 
exempt the owner or operator of the structural fill 
facility from applicable North Carolina Water 
Pollution Control Regulations (15A NCAC 2H). 
the North Carolina Air Pollution Control Regula- 
tions (15A NCAC 2D) and all other federal, state 
and local laws and regulations. 

Statutory Authority G. S 130A-294. 

.1710 ANNUAL REPORTING 

No later than October 1, 1993 and each October 
i thereafter, the generators of coal combustion by- 
products shall submit an annual summary to the 
Division. The annual summary shall be for the 
period July \ through June 31 and shall include: 

(1) Volume of coal combustion by-products 
produced; 

(2) Volume of coal combustion by-products 
disposed; 

(3) Volume of coal combustion by-products 
used in structural fill facilities; and 

(4) Volume of coal combustion by-products 
used for other uses as described jn Rule 
.1708 of this Section. 



Statutory Authority G.S. 130A-294. 

iSotice is hereby given in accordance with G.S. 
150B-21.2 that the EHNR - Commission for Health 
Services intends to amend rules cited as 15A 
NCAC 18A .0301, .0420, .0425, .0427. and repeal 
rules cited as ISA .0201 - .0230. 

1 he proposed effective date of this action is 
January 4, 1994. 

1 he public hearing will be conducted at 10:00 
a.m. on October 15, 1993 at the Archdale Build- 
ing, Groundfloor Hearing Room, 512 N. Salisbury 
Street, Raleigh, NC. 

Ixeason for Proposed Action: The proposed 
changes in the shellfish and scallop rules will 
bring these rules into conformity with the National 
Shellfish Sanitation Program (NSSP) Manual of 
Operations. 

(comment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P. O. Box 629, 
Raleigh, NC 27602-0629. All written comments 
must be received by October 20, 1993. Persons 
who \iish to speak at the hearing should contact 
John P. Barkley at (919)733-4618. Persons who 
call in advance of the hearing will be given 
priority on the speaker's list. Oral presentation 
lengths may be limited depending on the number of 
people that wish to speak at the public hearing. 
Only persons who have made comments at a public 
hearing or who have submitted written comments 
will be allowed to speak at the Commission 
meeting. Comments made at the Commission 
meeting must either clarify previous comments or 
proposed changes from staff pursuant to comments 
made during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS. GROUPS. BUSINESSES. 
ASSOCIATIONS, INSTITUTIONS OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 



1102 



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September 15, 1993 



PROPOSED RULES 



COMMENT PROCESS. WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED RULES. THE 
COMMISSION MAY MAKE CHANGES TO THE 
RULES AT THE COMMISSION MEETING IF THE 
CHANGES COMPLY WITH G.S 150B-21.2(f). 

CHAPTER 18 - ENVIRONMENTAL 
HEALTH 

SUBCHAPTER 18 A - SANITATION 

SECTION .0200 - SANITATION OF 
SCALLOPS 

.0201 DEFINITIONS 

The following definitions shall apply throughout 
15A NCAC 1 8 A .0200: 

^A) "Division" — means — the — Division — ef 

Environmental H e alth or its authoriz e d 
ag e nts. 

^3) "Soallopo" m e ans all varieti e s of bivalv e 

molluslcs of th e family PECTINIDAE. 

(^) "Sanitize" m e ans tiie approved 

baot e rioidal tr e atm e nt by a proc e ss which 
m ee ts — the — t e mp e ratur e — and — oh e mioal 
oono e ntmtion l e v e ls in 15A NCAC ISA 
t34WL 

(4) "Adult e rat e d" m e ans: — they contain any 

poisonous or delet e rious substanc e which 
may r e nd e r th e m injuriou s to th e h e alth 
of the consum e r; or that they have boon 
shuck e d, pack e d, stored, or transport e d 
und e r unsanitary condition s whereby they 
may — have — b e com e — contaminated — with 
filth, or wh e reby th e y may hav e b ee n 
r e nder e d — unwholesome or injurious to 
health; or that th e y have been shucked or 
pack e d in a plant that does not comply 
with thes e Rules and which do e s not hold 
a valid p e rmit from th e Division; or that 

th e y a-fe contaminated, filthy, 

d e compos e d, or oth e rwis e unfit for food; 
or that th e y ar e oth e rwis e adult e rat e d in 
accordanc e with th e provisions of G.S. 
106 129. 

{§) "Misbmndod" — m e ans: th e lab e ling is 

fals e or misleading in any particular; or 
that the labeling includ e s an id e ntification 
number which has not b ee n duly awarded 
to the plant by th e Division or which is 
not currently in e ff e ct; or that scallop 
m e at — is pack e d for sal e — in containers 
without lab e ling; or that they ar e other 
wis e misbranded in accordanc e with th e 



<^ 



provisions of G.S. 106 130. 
"Person" — moan s — afi — individual. 



firm. 



f?)- 



association, — organization, — partn e rship, 
busin e ss trust, corporation or company. 
"Shucking and packing plant" moans and 
includes any e stablishment or place in 
which scallops ar e shuck e d or packed for 
sale; provid e d that this definition shall 
not b e constru e d to m e an and include 
private residences whoso occupanto har 
v e st and shuck scallops for their own 
hom e consumption, — and — wbe — have — m 
th e ir poss e ssion not mor e than on e gallon 
of fr e sh, unfroz e n scallop m e at that v . 'as 
not pack e d in a plant approved by the 
Division. 



Statutory Authority G.S. 130A-230. 

.0202 ADULTERATED OR MISBRANDED 
SCALLOPS 

(a) No person within th e Stat e of North Carolina 
shall sell, off'er, or e xpos e for sale, or hav e in 
poss e ssion with intent to sell any scallops which 
ar e adulterat e d or misbrand e d. 

{b) — Wh e nev e r an authoriz e d ag e nt of the Divi 
sion finds adulterated or misbrand e d scallops in th e 
poss e ssion of any p e rson, the ag e nt is authoriz e d 

{V) giv e the p e rson notic e that h e is in 

violation of a rul e of th e Division and 
that l e gal action will be commenced; or 

{3^ in lieu of such notic e , allow the person 

to dispos e of th e scallops voluntarily in 
such a mann e r as to pr e clude the s ale of 
adulterat e d or misbrand e d s callop s . 

Statutory Authority G. S. 130A-230. 

.0203 GROWING AND GATHERING: 
SCALLOPS SHUCKED AT SEA 

(a) — Scallop s s hall b e harv es t e d only from thos e 
areas which have boon approv e d by th e stat e . 

(b) All boats and oth e r conveyanc e s used in th e 
harv e sting, handling, transportation, and storag e of 
scallops shall b e so construct e d and maintain e d in 
a state of cl e anlin e ss and repair that the scallops 
tran s port e d or s tored ther e in s hall not b e subject to 
contamination by bilg e water, filth, dust or v e r 
miriT 

(e) — Shell scallops shall b e k e pt cool during 
harv e sting, transportation, and holding. 

(d) Storage of scallop s in fresh water is prohibit 
edr 

^e) — Scallops shuck e d at sea ar e not r e quir e d to 



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1103 



PROPOSED RULES 



oomply with S e ction .0200 of this Subchapter. 

ff) — Scallops shuok e d at s e a muot be paolc e d in 
contain e rs approv e d by th e Division. 

(g) Containers of scallops, which ar e shuok e d at 
s e a. must b e lab e l e d as r e quir e d by th e Division. 

Statutory Authority G.S. 130A-230. 

.0204 SEVERABILITY 

If any provision of th e rules in 15A NCAC 1 8 A 
.0200 or the application thereof and any p>erson or 
ciroumstano e . i s held invalid, th e remaind e r of th e 
rules in thes e s e ctions or th e application of such 
provisions to other persons or ciroumstanocs shall 
not b e aff e ct e d th e r e by. 

Statutory Authority G.S. 130A-230. 

.0205 INSPECTION AND APPROVAL 

No p e rson shall op e rat e a shucking or packing 
plant for th e shucking or packing of scallops 
within th e Stat e of North Carolina until the facility 
complies with this S e ction and until ouch plant 
shall have been insp e ct e d and approv e d by the 
Division. 

Statutory Authority G.S. 130A-230. 

.0206 PERMITS 

(e) — No scallop shucking or packing plant shall 
bo op e rat e d in North Carolina until a p e rmit to 
operat e shall have been issu e d by th e Division. 

(b) A p e rmit to op e rat e shall b e issu e d only after 
a sanitary insp e ction or r e insp e ction by th e Divi 
sion Bhov . 's that th e plant complies V r 'ith this S e c 

(o) Permits issued to one person ar e not transf e r 
able to others. All permits shall e xpire annually on 
June 30. 



Statutory Authority G.S. 130A-230. 

.0209 SEPARATION OF OPERATIONS 

Th e r e shall b e provided a shucking and packing 
plant with a satisfactory sh e llstock storag e room, 
shucking room, and a packing room for th e stor 
ag e . shucking, and packing of scallops. 

Statutory Authority G.S. 130A-230. 

.0210 LIGHTING AND VENTILATION 

(a) — Natural or artificial lighting shall b e provid 
e d in all parts of the plant. — Light bulbs, fixtures, 
or other glass susp e nd e d within the plant shall be 
of saf e ty typo or otherwis e prot e ct e d to prevent 

contamination — m — ease — of breoJcago. Lighting 

intensities shall b e a minimum of 25 foot candles 
on working surfac e s — in packing and shucking 
rooms. 

fb) — V e ntilation shall b e provid e d to eliminate 
odors and cond e nsation. 

Statutory Authority G.S 130A-230. 

.0211 FLOORS 

Floors shall be of concr e t e or other equally 
imperviou s mat e rials, so construct e d that th e y may 
b e e asily and thoroughly clean e d and shall b e 
slop e d so that drainag e of all water ther e from shall 
be compl e te and rapid. 

Statutory Authority G. S. 130A-230. 

.0212 WALLS AND CEILINGS 

Walls and c e ilings of rooms in which scallops are 
stor e d. — shucked. — or pack e d. — shaH — be smooth, 
washabl e , light color e d, and k e pt in good repair. 

Statutory Authority- G.S. 130A-230. 



Statutory Authority G. S. 130A-230. 

.0207 APPLICATION 

Application for such insp e ction shall be made in 
writing — by — (be — person — requ e sting — a — p e rmit to 
op e rate. — All c e rtificat e s of insp e ction and p e rmits 
shall b e post e d in a conspicuous plac e in the 
packing room. 

Statutory Authority G. S 130A-230. 

.0208 REVOCATIONS 

Violation of any of th e rules of this S e ction shall 
constitut e suffici e nt cause for res'ooation of the 
p e rmit to op e rate. 



.0213 INSECT AND RODEP^ CONTROL 

The plant shall b e so construct e d as to pr e v e nt 
ready e ntranc e of fli e s. — rod e nts. — and domestic 
animals. — Screen s shall b e e ff^ e ctiv e and k e pt in 
good r e pair. 

Statutory Authority G.S 130A-230. 

.0214 SHUCKING BENCHES 

Shucking bench e s and th e wall s imm e diat e ly 
adjacent shall be construct e d of s mooth concr e t e or 
e qually imp e rvious mat e rials to a h e ight of at least 
two f ee t above the benches, and shall b e provid e d 
with ad e quat e and prop e r drainag e . 



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PROPOSED RULES 



Statutory Authority as. I30A-230. 

.0215 REFRIGERATION 

Refrigerators, ioe boxes, or oold storag e roomo 
shall maintain a temp e ratur e of 50 dogrooo F (10 
degrees C) or below, and shall bo oonotruot e d to 
permit easy and thorough cl e aning and prop e r 
drainag e and shall b e kept cl e an. 

Statutory Authority G.S 130A-230. 

.0216 TOILET FACILITIES 

Separate and conv e ni e nt toilet faciliti e s shall b e 
provid e d for each s e x e mploy e d and shall comply 
with the N.C. State Building Cod e , Volum e 2, 
Plumbing. — Floors, walls, and ceilings shall b e 
smooth, easily cl e anabl e and kept clean. — Fixtures 
shall be kept clean. — All toil e t wast e s and other 
s e wag e shall b e dispos e d of in a public s e w e r 
system or in th e absenc e of a public s e w e r syst e m, 
by an on sit e s e wag e disposal system approv e d by 
the — D e partm e nt — ifl — accordanc e — with — G.S. 
130A335. 



Statutory Authority G.S. 130A-230. 

.0220 CONSTRUCTION OF EQUIPMENT 

Shucking — pails, — skimmers, — tubs, — knives, — and 
oth e r e quipm e nt which may come in direct contact 
with — shuck e d — scallops — &haH — be — made — ef 
non corrosive, — non rusting, — smooth, — imp e rvious 
mat e rial — and — construct e d — se — as — te — be — easily 
cleanable. 

Statutory Authority G.S. 130A-230. 

.0221 PERSONAL HEALTH 

No p e rson shall work in th e handling, shucking 
or packing of scallops, who has any communicable 
diseas e or has any op e n lesions or sor e s. 

Statutory Authority G.S. 130A-230. 

.0222 PERSONAL HYGIENE 

All employees shall wash their hands thoroughly 
with warm water and soap b e for e beginning work 
and aft e r each visit to th e toil e t. 



Statutory Authority G.S 130A-230. 

.0217 WATER SUPPLY 

{a) The — plants — shall — be — provid e d — with — as 

ad e quate supply of wat e r und e r pr e ssur e from a 
sourc e approved by the Division. 

(b) An automatically regulat e d hot water system 
shall b e provid e d. 

Statutory Authority G.S. 130A-230. 

.0218 HAND WASHING FACILITIES 

Hand washing facilities including lavatories, hot 
afld — eeW — running — water, — soap, — and — individual 
towels shall be provid e d in a convenient plac e in 
th e shucking room. 

Statutory Authority G.S 130A-230. 

.0219 WASHING AND SANITIZING 
FACILITIES 

Washing and — s anitizin g — faciliti e s — including — a 
two compartm e nt sinlc of sufficient size to wash 
and sanitiz e all utensil s s hall b e provid e d. — Perma 
n e nt hot and oold water conn e ctions shall b e 
inotoll e d so that both vats may rec e ive hot and oold 
V t Tit e r service. — Hot wat e r of 170 degrees F. or 
abov e , or a standard chlorin e solution shall be 
provid e d for th e sanitization of utensils and e quip 
ment. 



Statutory Authority G.S. 130A-230. 

.0223 WASHING OF SCALLOPS 

Scallops shall b e shuck e d only in th e shucking 
room and in such a mann e r that th e y ar e not 
subj e ct to contamination or adulteration. — Shuck e d 
scallop meats shall be wash e d on a skimmer with 
cold running wat e r only, for but not more than 
thr e e minute s . — Th e wa s hing of s huck e d scallop 
meat s — in — non perforated — vessels — h — prohibit e d. 
Shuck e d scallops shall b e fr ee of grass, sh e ll, and 
oth e r e xtraneous material. 

Statutory Authority G. S 130A-230. 

.0224 CONTAINERS 

Shuck e d scallops shall b e pack e d and shipp e d in 
approv e d singl e s e rvic e contain e rs sealed in such 
a manner that tampering may b e ea s ily di s c e rnibl e , 
and mark e d with the nam e and addr e ss of th e 
pack e r, — and — the — packer's — certificate — number 
impress e d — ef — e mbossed — en — the — side — of such 
container. — Use of contain e rs b e aring th e c e rtificat e 
number of anoth e r pack e r s hall not be permitted. 

Statutory Authority G.S 130A-230. 

.0225 PACKING 

Shuck e d scallop meats shall be pack e d within on e 
hour of shucking. Pack e d s callop m e ats shall b e 
cooled to 50 degre e s F. or less within three hours 



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PROPOSED RULES 



aft e r — packing, — and — stor e d — aad — shipp e d — und e r 
similar tomp e mtur e oonditions. 

Statutory Authority G. S. 130A-230. 

.(ill6 CLEANSEVG OF EQUIPMENT 

All ut e nsils and tools which oom e in oontaot with 
soallop m e ats shall b e thoroughly wash e d aft e r us e 
and s ubjected to an approv e d baot e rioidal proocss: 

^4-) by — imm e rsing — m — het — water — at — a 

t e mp e rature of 170 degrees F. or more 
for at least two minut e s, or 

{3^ by imm e rsing in a solution containing no 

loss than 50 parts p e r million of availabl e 
chlorine for two minut e s. 

Statutory Authority G.S. 130A-230. 

mil INTERIOR OF PLANTS 

Th e int e rior of all shucking and packing plants 
shall be kept clean. Non e of th e op e rations shall b e 
conducted — m — any — room — ttsed — fer — domestic 
purpos e s. 

Statutory Authority G.S. 130A-230. 

.0228 WASTE DISPOSAL 

Scallop sh e lls, unused parts of soallop bodi e s, 
washings, and oth e r wastes shall be disposed of in 
a sanitary mann e r, as approv e d by th e Division. 

Statutory Authority G.S 130A-230. 

.0229 REPACKING 

(a) — Shuck e d scallops to b e r e pack e d shall be 
r e c e iv e d — at — the — r e packing — plant — m — approv e d 
shipping contamers at a t e mp e rature of 50 degr e es 
F. or loss. 

fb) During th e r e packing — process. — shuck e d 

scallops shall be h e ld at a t e mp e ratur e suffici e nt to 
pr e v e nt d e t e rioration and shall — b e stor e d at a 
t e mperatur e of 50 degrees F. or loss. 

{e) — During th e r e packing process, handling and 
storag e of scallop s shall b e don e in a sanitary 
mann e r as prescrib e d in thes e Rules. 

{4j — R e pack e d scallops shall b e repack e d and 
shipp e d — m — approved s ingl e — se rvic e — contain e rs 
s e al e d in such a manner that tamp e ring may b e 
e asily disc e rnibl e , and mark e d with th e nam e and 
address — ©f — the — r e pack e r — and — the — r e paok e r's 
c e rtificat e numb e r. — Us e of containers bearing th e 
c e rtificat e number of anoth e r packer or r e packer 
shall not b e p e rmitted. 

Statutory Authority G.S 130A-230. 



.0230 APPEALS PROCEDURE 

App e als shall b e conduct e d in accordanc e with 
G.S. 150B. 

Statutory Authority G.S. 130A-230. 

SECTION .0300 - SANITATION OF 
SHELLFISH - GENERAL 

.0301 DEFINITIONS 

The following definitions shall apply throughout 
this Subchapter: 

(1) "Adulterated" means the following: 

(a) Any shellfish that have been harvested 
from prohibited areas; 

(b) Any shellfish that have been shucked, 
packed, or otherwise processed in a 
plant which has not been permitted by 
the Division in accordance with these 
Rules; 

(c) Any shellfish which exceed the 
bacteriological standards in Rule .0430 
of this Subchapter; 

(d) Any shellfish which are putrid or unfit 
for human consumption; 

(e) Any shellfish which have been exposed 
to any unsanitary conditions; or 

(f) Any shellfish which contain any added 
substance, unless the substance is 
approved by the Division or the United 
States Food and Drug Administration. 

(2) "Approved area" means an area 
determined suitable for the harvest of 
shellfish for direct market purposes. 

(3) "Bulk shipment" means a shipment of 
loose shellstock. 

(4) "Buy boat or buy truck" means any 
approved boat or truck that is used by a 
person permitted under these Rules to 
transport shellstock from one or more 
harvesters to a facility permitted under 
these Rules. 

(5) "Depuration" means mechanical 
purification or the removal of 
adulteration from live shellstock by any 
artificially controlled means. 

(6) "Depuration facility" means the physical 
structure wherein depuration is 
accomplished. including all the 
appurtenances necessary to the effective 
operation thereof. 

(7) "Division" means the Division of 
Environmental Health or its authorized 
agent. 

(8) "Heat shock process" means the practice 



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PROPOSED RULES 



of heating shellstock to fecilitate removal 
of the shellfish meat from the shell. 

(9) "Misbranded" means the following: 

(a) Any shellfish which are not labeled 
with a valid identification number 
awarded by regulatory authority of the 
state or territory of origin of the 
shellfish; or 

(b) Any shellfish which are not labeled as 
required by these Rules. 

(10) "Operating season" means the season of 
the year during which a shellfish product 
is processed. 

(11) "Person" means an individual, 
corporation, company, association, 
partnership, unit of government or other 
legal entity. 

(12) "Prohibited area" means an area 
unsuitable for the harvesting of shellfish 
for direct market purposes. 

(13) "Relaying or transplanting" means the act 
of removing shellfish from one growing 
area or shellfish grounds to another area 
or ground for any purpose. 

(14) "Repacking plant" means a shipper, other 
than the original shucker-packer, who 
repacks shucked shellfish into containers 
for delivery to the consumer. 

(15) "Reshipper" means a shipper who ships 
shucked shellfish in original containers, 
or shellstock, from permitted shellstock 
dealers to other dealers or to consumers. 

(16) "Sanitary survey" means the evaluation 
of factors having a bearing on the 
sanitary quality of a shellfish growing 
area including sources of pollution, the 
effects of wind, tides and currents in the 
distribution and dilution of polluting 
materials, and the bacteriological quality 
of water, 

(17) "Sanitize" means the approved 
bactericidal treatment by a process which 
provides sufficient accumulative heat or 
concentration of chemicals for sufficient 
time to reduce the bacterial count, 
including pathogens, to a safe level on 
utensils and equipment. 

(18) "SELL BY date" means a date 
conspicuously placed on a container or 
tag by which a consumer is informed of 
the latest date the product will remain 
suitable for sale. 

(19) "Shellfish" means oysters, mussels, 
scallops and all varieties of clams. 
Scallops are to be excluded when the 



final product is the shucked adductor 
muscle only. 

(20) "Shellstock" means any shellfish which 
remain in their shells. 

(21) "Shellstock conveyance" means all 
trucks, trailers, or other conveyances 
used to transport shellstock. 

(22) "Shellstock dealer" means a person who 
buys, sells, stores, or transports or causes 
to be transported shellstock which was 
not obtained from a person permitted 
under these Rules. 

(23) "Shellstock plant" means any 
establishment where shellstock are 
washed, packed, or otherwise prepared 
for sale. 

(24) "Shucking and packing plant" means any 
establishment or place where shellfish are 
shucked and packed for sale. 

(25) "Wet storage" means the temporary 
placement of shellstock from approved 
sources, in approved natural sea water. 

Statutory Authority G.S. 130A-230. 

SECTION .0400 - SANITATION OF 

SHELLFISH - GENERAL OPERATION 

STANDARDS 

.0420 TRANSPORTING SHELLSTOCK 

(a) All shellstock storage areas in trucks, buy 
boats, buy trucks, trailers, and other conveyances 
used for transporting shellstock shall be enclosed, 
tightly constructed, painted with a light color 
washable paint, kept clean, and shall be subject to 
inspection by the Division. 

(b) Shellstock shall be shipped under 
temperature and sanitary conditions in accordance 
with these Rules which will keep them alive and 
clean and will prevent adulteration or 
deterioration. During th e months of April through 
Octob e r, inclusiv e , a All shellstock shall be kept 
under mechanical refrigeration at a temperature of 
50°F (10°C) or below. All conveyances used to 
transport shellstock shall be equipped with an 
operating thermometer. 

(c) Buy boats and buy trucks shall be kept clean 
with water from a source approved by the Division 
under Rule .0413 of this Subchapter. Buy boats 
and buy trucks shall provide storage space for 
clean shipping containers, identification tags, and 
records. 

Statutory Authority G. S. 130A-220. 



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1107 



PROPOSED RULES 



m 



13} 
£41 
15} 
16} 



.0425 TAGGING 

(a) In order that information may be available to 
the Division with reference to the origin of 
shellstock, containers holding shellstock shall be 
identified with a uniform tag or label. If 
shcllotoek is sold dir e ctly to the final consum e r. 
the — permitt e d — d e al e r — must — display — its — nam e , 
addr e ss, and p e rmit numb e r in full view of the 
buying public, in lieu of individual shipping tags. 
if — shellstock — k — te — be — r es old — ef — seW — te — a 
comm e rcial establishm e nt, e ach individual package 
shall — be — lab e l e d — ef — tagg e d — with — the — required 
information. TTie tag shall be durable, waterproof 
and measure at least 2-5/8 by 5-1/4 inches (6.7 by 
13.3 centimeters). The tag shall contain legible 
information arranged in specific order as follows: 
(1) the dealer's name, address and 
certification number assigned by the 
appropriate shellfish control agency; 
the original shipper's certification 
number, including the country or state 
abbreviation: 
the har\'est date; 
the harvest location; 
the type and quantity of shellfish; and 
the following statement shall appear in 
bold capitalized ts'pe "THIS TAG IS 
REQUIRED TO BE ATTACHED 
UNTIL CONTAINER IS EMPT\^ 
AND THEREAFTER KEPT ON 
FILE FOR 90 DAYS. 
(h) Th e information upon th e tag or lab e l shall 
includ e th e name and addr e ss of shipper, permit 
number issu e d by th e Division, together with th e 
state — abbr e viation, — date — of harv es ting, — date — ef 
shipm e nt or of reshipment. and name of th e waters 
from which th e sh e llfish wer e harv e st e d. TTie 
uniform tag or label shall remain attached to the 
shellstock container until the container ]s empty 
and thereafter shall be kept on fije for 90 days. 

fe-) — TTi e stub of th e tag s hall not b e r e mov e d 
from any packag e of sh e llstock until all of th e 
cont e nts of th e packag e hav e b e en r e moved. — ftgs 
shall b e durable, wat e rproof, and l e gibl e . 

fd-)(c) All shellstock from a depuration facility 
must be identified as having been cleansed by a 
depuration facility identified by a name and permit 
number on the tag. 

Statutory Authority G. S. 130A-230. 

.0427 SHELLSTOCK STORAGE 

Shellstock held in wet or dry storage must be 
kept so that they will not become adulterated. All 
shellstock held in dry storage during th e months of 



April through October, inclusive, shall be kept 
under mechanical refrigeration at a temperature of 
50°F (10°C) or below. All refrigerated shellstock 
storage areas shall be equipped with an operating 
thermometer. 

Statutory Authority G.S. 130A-230. 

****************** 

iSotice is hereby given in accordance mth G.S. 
!50B-21.2that the EHNR - Commission for Health 
Serxices intends to amend rules cited as 15A 
NCAC 18A .2601. .2638 - .2639, and .2810. 

1 he proposed effective date of this action is 
January 4. 1994. 

1 he public hearing will be conducted at 10:00 
a.m. on October 15, 1993 at the Archdale Build- 
ing, Groundfloor Hearing Room, 512 N. Salisbury 
Street, Raleigh, NC. 

txeason for Proposed Action: 
ISA NCAC 18A .2601; .2638: .2639 - To allow 
new uses for pushcarts. To change food prepara- 
tions to more controlled environments. 

15A NCAC 18A .2810 - To amend Day Care food 
equipment rules to allow domestic stoves in all but 
large day care facilities or facilities engaged in 
catering. 

l^omment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P.O. Box 629, 
Raleigh, NC 27602-0629. All written comments 
must be received by October 20, 1993. Persons 
who wish to speak at the hearing should contact 
John P Barkley at (919)733-4618. Persons who 
call in advance of the hearing will be given 
priority on the speaker's list. Oral presentation 
lengths may be limited depending on the number of 
people that wish to speak at the public hearing. 
Only persons who have made comments at a public 
hearing or who have submitted written comments 
will be allowed to speak at the Commission 
meeting. Conmients made at the Commission 
meeting must either clarify previous comments or 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



proposed changes from staff pursuant to comments 
made during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS, GROUPS, BUSINESSES, 
ASSOCIAHONS, INSmVTIONS OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS, WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED RULES. THE 
COMMISSION MAY MAKE CHANGES TO THE 
RULES AT THE COMMISSION MEETING IF THE 
CHANGES COMPLY WITH G.S. 1503-21. 2(f). 

CHAPTER 18 - ENVIRONMENTAL 
HEALTH 

SUBCHAPTER 18 A - SANITATION 

SECTION .2600 - SANITATION OF 

RESTAURANTS AND OTHER 

FOODHANDLING 

ESTABLISHMENTS 

.2601 DEFINITIONS 

The following definitions shall apply in the 
interpretation and enforcement of this Section: 
(1) "Approved" means determined by the 
Department to be in compliance with this 
Section. Food service equipment which 
meets National Sanitation Foundation 
standards or equal shall be considered as 
approved. The National Sanitation 
Foundation Commercial Food Service 
Equipment Standards are hereby 
incorporated by reference including any 
subsequent amendments and editions. 
This material is available for inspection 
at the Department of Environment, 
Health, and Natural Resources, Division 
of Environmental Health, 1330 St. 
Mary's Street, Raleigh, North Carolina. 
Copies may be obtained from NSF 
International, RO. Box 13014, Ann 
Arbor, Michigan 48113-0140, at a cost 
of three hundred and twenty five dollars 
($325.00). Food which complies with 
requirements of the North Carolina 
Department of Agriculture or United 
States Department of Agriculture and the 
requirements of this Section shall be 
considered as approved. 



(2) "Catered elderly nutrition site" means an 
establishment or operation where food is 
served, but not prepared on premises, 
operated under the guidelines of the N.C. 
Department of Human Resources, 
Division of Aging. 

(3) "Department of Environment, Health, 
and Natural Resources" or "Department" 
means the North Carolina Department of 
Environment, Health, and Natural 
Resources. The term also means the 
authorized representative of the 
Department. 

(4) "Drink stand" means those establishments 
in which only beverages are prepared on 
the premises and are served in multi-use 
containers, such as glasses or mugs. 

(5) "Eating and cooking utensils" means any 
kitchenware, tableware, glassware, 
cutlery, utensils, containers, or other 
equipment with which food or drink 
comes in contact during storage, 
preparation, or serving. 

(6) "Employee" means any person who 
handles food or drink during preparation 
or serving, or who comes in contact with 
any eating or cooking utensils, or who is 
employed at any time in a room in which 
food or drink is prepared or served. 

(7) "Food" means any raw, cooked, or 
processed edible substance, ice, 
beverage, or ingredient used or intended 
for use or for sale in whole or in part for 
human consumption. 

(8) "Food stand" means those food service 
establishments which prepare or serve 
foods and which do not provide seating 
facilities for customers to use while 
eating or drinking. Establishments which 
only serve such items as dip ice cream, 
popcorn, candied apples, or cotton candy 
are not included. 

(9) "Hermetically sealed container" means a 
container designed and intended to be 
secure against the entry of 
micro-oiTganisms and to maintain the 
commercial sterility of its contents after 
processing. 

(10) "Local Health Director" means the 
administrative head of a local health 
department or his authorized 
representative. 

(11) "Mobile food unit" means a 
vehicle-mounted food service 
establishment designed to be readily 



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1109 



PROPOSED RULES 



moved. 

(12) "Person" means any individual, firm, 
association, organization, partnership, 
business trust, corporation, or company. 

(13) "Potentially hazardous food" means any 
food or ingredient, natural or synthetic, 
in a form capable of supporting the 
growth of infectious or toxigenic micro- 
organisms, including Clostridium botuli- 
num. This term includes raw or heat 
treated foods of animal origin, raw seed 
sprouts, and treated foods of plant origin. 
The term does not include foods which 
have a pH level of 4.6 or below or a 
water activity (Aw) value of 0.85 or less. 

(14) "Private club" means a private club as 
defined in G.S. 130A-247(2). 

(15) "Pushcart" means a mobile piece of 
equipment or vehicle which serves eely 
bet — degs foods which have been 
prepared, pre-portioned, and individually 
wrapped at a restaurant. The term also 
includes pushcarts permitted prior to 
January \^ 1994 which prepare, handle, 
or serve only hot dogs . 

(16) "Responsible person" means the 
individual present in a food service 
establishment who is the apparent 
supervisor of the food service 
establishment at the time of inspection. 
If no individual is the apparent 
supervisor, then any employee is the 
responsible person. 

(17) "Restaurant" means all establishments 
and operations where food is prepared or 
served at wholesale or retail for pay, or 
any other establishment or operation 
where food is prepared or served that is 
subject to the provisions of G.S. 
130A-248. The term does not include 
establishments which only serve such 
items as dip ice cream, popcorn, candied 
apples, or cotton candy. 

(18) "Sanitarian" means a person authorized 
to represent the Department on the local 
or state level in making inspections 
pursuant to state laws and rules. 

(19) "Sanitize" means the approved 
bactericidal treatment by a process which 
meets the temperature and chemical 
concentration levels in 15A NCAC ISA 
.2619. 

(20) "Sewage" means the liquid and solid 
human body waste and liquid waste 
generated by water-using fixtures and 



appliances, including those associated 
with foodhandling. The term does not 
include industrial process wastewater or 
sewage that is combined with industrial 
process wastewater. 

(21) "Single service" means cups, containers, 
lids, closures, plates, knives, forks, 
spoons, stirrers, paddles, straws, 
napkins, wrapping materials, toothpicks, 
and similar articles intended for one-time, 
one person use and then discarded. 

(22) "Temporary food stand" means those 
food or drink stands which operate for a 
period of 15 days or less, in connection 
with a feir, carnival, circus, public 
exhibition, or other similar gathering. 

(23) "Temporary restaurant" means a 
restaurant, as defined in Item (17) of this 
Rule, that operates for a period of 15 
days or less, in connection with a fair, 
carnival, circus, public exhibition, or 
other similar gathering. 

Statutory Authority G.S. 130A-248. 

.2638 GENERAL REQUIREMENTS FOR 

PUSHCARTS AND MOBILE FOOD 
UNITS 

(a) Approval A permit shall be gmnt e d issued 
by the local health department which provides 
sanitation surveillance for the restaurant from 
which the pushcart or mobile food unit is to 
operate, if the local health department determines 
that the pushcart or mobile food unit complies with 
these Rules. 

(h) The writt e n approval permit shall be in the 
pogoesoion of the p e rson op e rating posted on the 
pushcart or mobile food unit. Grade cards shall 
not be posted. 

(c) The local health department which issues 
approval the permit shall be provided by individu- 
als receiving approval a list of counties and loca- 
tions where each pushcart or mobile food unit will 
operate. 

(d) Individuals receiving approval a permit to 
operate a pushcart or mobile food unit shall pro- 
vide the local health department in each county in 
which food service operations are proposed a list 
of locations where they will operate. Such lists 
must be kept current. 

(e) Prior to initiating food service operations in 
a particular jurisdiction, the operator of the push- 
cart or mobile food unit shall submit to that partic- 
ular jurisdiction such carts or units for inspection 
or reinspection to determine compliance with this 



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PROPOSED RULES 



Section. 

(f) Such carts or units shall operate in conjunc- 
tion with a permitted restaurant and shall report at 
least daily to the restaurant for supplies, cleaning, 
and servicing. Sanitary storage facilities shall be 
provided at the restaurant for storage of all sup- 
plies. The pushcart shall also be stored in a 
sanitary area. Water faucets used to supply water 
for pushcarts and mobile food units shall be 
protected to prevent contact with chemicals, splash 
and other sources of contamination. Solid waste 
storage and liquid waste disposal facilities must 
also be provided on the restaurant premises. 

(g) All foods shall be obtained from approved 
sources and shall be handled in a manner so as to 
be clean, wholesome, and free from adulteration. 

(h) All potentially hazardous foods shall be 
maintained at 45° F (7° C) or below or 140° F 
(60° C) or above, or as required in Rule .2609 of 
this Section. A metal stem-type thermometer 
accurate to + 2° F (± 1° C.) shall be available 
to check food temperatures. 

(i) Only single-service eating and drinking 
utensils shall be used in serving customers. 
Single-service items must be properly stored and 
handled. 

(j) All garbage and other solid waste shall be 
stored and disposed of in an approved manner. 

(k) Employees shall be clean as to their person 
and foodhandling practices. Clean outer clothing 
and hair restraints are required. 

(1) No person who has a communicable or 
infectious disease that can be transmitted by foods, 
or who is a carrier of organisms that cause such a 
disease, or who has a boil, infected wound, or an 
acute respiratory infection with cough and nasal 
discharge, shall work with a pushcart or mobile 
food unit in any capacity in which there is a 
likelihood of such person contaminating food or 
food-contact surfaces, with disease-causing organ- 
isms or transmitting the illness to other persons. 

(m) All equipment and utensils shall be easily 
cleanable and kept clean and in good repair. 

(n) The pushcart or mobile food unit shall be 
kept in a clean and sanitary condition and be free 
of flies, roaches, rodents, and other vermin. 

Statutory Authority G.S. 130A-248. 

.2639 SPECIFIC REQUIREMENTS 
FOR PUSHCARTS 

(a) Only hot dogs shall be prepared, handled, or 
served from a pushcart granted approval prior to 
January L, 1994. All pushcarts permitted after 
January L, 1994 shall serve only foods which have 



been prepared, pre-portioned and individually pre- 
wrapped at a restaurant. 

(b) Food and utensils on the cart exposed to the 
public or to dust or insects shall be protected by 
glass, or otherwise, on the front, top, and ends, 
and exposed only as much as may be necessary to 
permit the handling and serving of hot dogs. 

(c) Toilet facilities, lavatory facilities, and 
running water are not required. Single-service 
towels are required. 

(d) The permit applicant shall provide third 
party documentation to the Department which 
demonstrates the ability of all pre-portioned, 
individually pre-wrapped foods placed on the 
pushcart to hold temperatures under conditions 
approximating actual use, for the time periods 
specified by the permit applicant. 

(e) Each pre-wrapped food item shall bear the 
name of the restaurant at which it was prepared. 
the name of the food item and the time and date of 
preparation. The wrapp er shall cover the food at 
all times but sealing js not required. 

(f) Pre-portioned, individually pre-wrapped food 
that remains after the specified time period has 
elapsed shall not be sold for human consumption. 

(g) Pushcarts shall not be provided with seating 
facilities. 

(h) Pushcarts shall not be used for consumer 
self-service. 

Statutory Authority G.S. 130A-248. 

SECTION .2800 - SANITATION OF 
CfflLD DAY CARE FACILITIES 

.2810 SPECIFICATIONS FOR KITCHENS, 
BASED ON NUMBER OF CHILDREN 

(a) Day Care Facilities Licensed for 6-24 Chil- 
dren: 

(1) Domestic kitchen equipment may be 
used. Domestic kitchen equipment 
shall include at least a two-compartment 
sink, dishwasher, refrigeration equip- 
ment, and cooking equipment. In lieu 
of a dishwasher and two-compartment 
sink, a three-compartment sink may be 
used. Day care facilities using only 
single-service articles shall provide at 
least a two-compartment sink; 

(2) A separate lavatory for handwashing is 
required in the kitchen. This hand- 
washing lavatory shall be used only by 
foodservice personnel; 

(3) After each use, all multi-use tableware 
and food-contact surfaces of equipment 



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September 15, 1993 1111 



PROPOSED RULES 



and utensils shall be washed and rinsed 
in a dishwasher or three-compartment 
sink. Sanitization shall then take place 
in the sink by immersion for at least 
one minute in clean, hot water at least 
170°F or at least two minutes in a clean 
solution containing: 

(A) At least 50 parts per million of avail- 
able chlorine at a temperature of at 
least 75°F (24°C); 

(B) At least 12.5 parts per million of 
available iodine and having a pH not 
higher than 5.0 and at a temperature 
of at least 75 °F (24°C); or 

(C) At least 200 parts per million of 
quaternary ammonium products and 
having a temperature of at least 75 °F 
(24 °C), provided that the product is 
labeled to show that it is effective in 
water having a hardness value at least 
equal to that of the water being used. 

(b) Day Care Facilities Licensed for 25 or More 
Children; 

(1) Kitchen equipment requirements shall 
include the following: 

(A) Commercial kitchen equipment meet- 
ing NSF (National Sanitation Founda- 
tion) standards or equivalent shall be 
required in day care facilities licensed 
for 25 or more children; however, 
domestic stoves may be used in day 
cares licensed for or serving food to 
79 or fewer people. 

(B) Commercial kitchen equipment shall 
include at least a three-compartment 
sink with drainboards, refrigeration 
equipment, and cooking equipment. 

(2) A separate food preparation sink with 
drainboard shall be provided for the 
washing and processing of foods except 
where plan review shows that volume 
and preparation frequency do not re- 
quire separate facilities. 

(3) A separate lavatory for handwashing is 
required in the kitchen. This hand- 
washing lavatory shall be used only by 
food service personnel. 

(4) Day care facilities using single-service 
utensils and not preparing food other 
than simple snacks, shall provide at 
least a two-compartment sink with 
drainboards, refrigeration equipment, 
and a separate handwashing lavatory. 

(c) Equipment that was installed in a day care 
facility prior to the effective date of these Rules 



and that does not meet all the design and fabrica- 
tion requirements of this Section shall be deemed 
acceptable if it is in good repair, capable of being 
maintained in a sanitary condition, and the food-- 
contact surfaces are nontoxic. Replacement 
equipment and new equipment acquired after the 
effective date of these Rules shall meet the require- 
ments of this Section. Upon change of ownership, 
or the closing of the operation and the issuance of 
a new license, the day care facility shall comply 
with all the rules of this Section. 

Statutory Authority G.S. 110-91. 

****************** 

iSotice is hereby given in accordance with G.S. 
150B-21.2 that EHNR - Commission for Health 
Services intends to amend rules cited as 15A 
NCAC 18C .0102. .0201 - .0203, .0301 - .0303. 
.0305, .0307- .0308, .0401 - .0405, .0407. .0501 
- .0502. .0703, .0708. .0802 - .0805, .1002. 
. 1004. . 1207, . 1209, .1211. . 1301 - . 1303, . 1406; 
and adopt rules cited as 15A NCAC 18C .0409. 
.0710- .0715, .1537. 

1 he proposed effective date of this action is 
January 4, 1994. 

1 he public hearing will be conducted at 10:00 
a.m. on October 15. 1993 at the Groundfloor 
Hearing Room, Archdale Building, 512 N. Salis- 
bury Street, Raleigh , N. C. 

IXeason for Proposed Action: 

15A NCAC 18C .0102 - to clarify the applicability 
of these Rules by adding new definitions. 
ISA NCAC 18C .0201 - to allow non-transient, 
non-community water .^'stenis to use surface water 
supply without filtration subject to appropriate 
rules. 

15A NCAC 18C .0202 - to incorporate the ex- 
panded water supply watershed classification 
categories adopted by the Environmental Manage- 
ment Commission as applicable to treatment of 
surface water by all public water systems. 
ISA NCAC 18C .0203 - to increase the protection 
of well water supplies and include non-transient. 
non-comnumit\ wells. 

ISA NCAC 18C .0301 - .0308 - to expand the 
applicability of the requirements for submitting 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



plans, specifications, and reports to include non- 
transient, non-community water systems. 
ISA NCAC 18C .0401 - to expand the applicabili- 
ty of the minimum design requirements for approv- 
al of plans and specifications to include non- 
transient, non-community water systems. 
ISA NCAC 18C .0402 - to increase the protection 
of well water supplies and clarify the yield and 
laboratory certification requirements. 
ISA NCAC 18C .0403 - to allow flexibility in the 
maximum daily draft of a water treatment plant 
from unimpounded streams and allow for existing 
impoundments to be approved as raw water sourc- 
es. 

ISA NCAC ISC .0404 - to increase the protection 
of water treatment facilities. 
ISA NCAC 18C .040S - to modify the design 
criteria for hydropneumatic water storage tanks. 
ISA NCAC 18C .0407 - to increase the protection 
of electrical systems. 

ISA NCAC 18C .0409 - to establish and clarify 
the limitations on service connections to public 
water supply systems with and without a local 
water supply plan. 

ISA NCAC 18C .OSOl - to retitle the Section. 
ISA NCAC 18C .0S02 - to expand the applicabili- 
ty of the supplemental design criteria to include 
non-transient, non-community water systems and to 
provide for the approval of alternate designs. 
ISA NCAC 18C .0703 - to delineate the design 
requirements for flocculator paddles. 
ISA NCAC 18C .0708 - to provide more detailed 
design requirements fi>r gravity filters. 
ISA NCAC 18C .0710 - to establish the require- 
ments fi)r use of direct filtration. 
ISA NCAC 18C .0711 - to establish the require- 
ments for use of package water treatment plants. 
ISA NCAC 18C .0712 - to establish the limitations 
and requirements for use of pressure filters. 
ISA NCAC 18C .0713 - to establish the require- 
ments fijr use of alternative filtration technologies. 
ISA NCAC 18C .0714 - to establish the require- 
ments for pilot plant studies. 
ISA NCAC 18C .071S - to establish the standards 
for evaluation of water system design features not 
otherwise specifically addressed. 
ISA NCAC 18C .0802 - to expand the requirement 
for water systems to use peak demand charts to 
include campgrounds and non-transient, non- 
community systems. 

ISA NCAC 18C .0803 - to expand the pressure 
tank volume requirement to include campgrounds. 
ISA NCAC 18C .0804 - to remove unnecessary 
reference. 



ISA NCAC 18C .0805 - to expand the elevated 
storage capacity requirement to include community 
and non-transient, non-community water systems. 
ISA NCAC 18C .1002 - to clarify the requirements 
for disinfection of wells. 

ISA NCAC 18C .1004 - to provide for the disin- 
fection of filters using an alternative to chlorine. 
ISA NCAC 18C .1207 - to ease the restrictions on 
animals in the margins of reservoirs. 
ISA NCAC 18C .1209 - to incorporate the ex- 
panded water supply watershed classification 
categories adopted by the Environmental Manage- 
ment Commission as applicable to protection of 
reservoirs. 

ISA NCAC 18C .1211 - to incorporate the ex- 
panded water supply watershed classification 
categories adopted by the Environmental Manage- 
ment Commission as applicable to ground absorp- 
tion sewage systems. 

ISA NCAC 18C .1301 - to broaden the applicabil- 
ity of the requirements for the operator in charge 
from Just community to all public surface water 
systems requiring disinfection only and to clarify 
information required on monthly reports. 
ISA NCAC 18C .1302 - to broaden the applicabil- 
ity of the requirements for the operator in charge 
from just community to all filtered public water 
systems, to incorporate the expanded water supply 
watershed classification categories adopted by the 
Environmental Management Commission, and to 
clarify' information required on monthly reports. 
ISA NCAC 18C .1303 - to broaden the applicabil- 
ity of the requirements for the operator in charge 
to include non-transient, non-community well 
systems and to clarify information required on 
monthly reports. 

ISA NCAC 18C .1406 - to increase the fluoride 
reporting frequency from monthly to weekly. 
ISA NCAC 18C .1S37- to establish the standards 
for drinking water additives. 

(comment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P. O. Box 629, 
Raleigh, NC 27602-0629. All written comments 
must be received by October 20, 1993. Persons 
who wish to speak at the hearing should contact 
John P Barkley at (919)733-4618. Persons who 
call in advance of the hearing will be given priori- 
ty on the speaker's list. Oral presentation lengths 
may be limited depending on the number of people 
that wish to speak at the public hearing. Only 



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September IS, 1993 1113 



PROPOSED RULES 



persons who have made comments at a public 
hearing or who have submitted written comments 
will be allowed to speak at the Commission meet- 
ing. Comments made at the Commission meeting 
must either clarify prexious comments or proposed 
changes from staff pursuant to comments made 
during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL INTEREST- 
ED AND POTENTIALLY AFFECTED PERSONS, 
GROUPS. BUSINESSES, ASSOCIATIONS, INSTI- 
TUTIONS OR AGENCIES MAKE THEIR VIEWS 
AND OPINIONS KNOWN TO THE COMMISSION 
FOR HEALTH SERVICES THROUGH THE PUB- 
LIC HEARING AND COMMENT PROCESS, 
WHETHER THEY SUPPORT OR OPPOSE ANY 
OR ALL PROVISIONS OF THE PROPOSED 
RULES. THE COMMISSION MAY MAKE 
CHANGES TO THE RULES AT THE COMMIS- 
SION MEETING IF THE CHANGES COMPLY 
WITH G.S I50B-21.2(f). 

Fiscal Note: ISA NCAC 18C .0203 affects the 
expenditures or re\'enues of local funds. A fiscal 
note was submitted to the Fiscal Research Division 
on August 24. 1993. OSBM on August 24, 1993, 
N.C League of Municipalities on August 27, 1993, 
and N. C Association of County Commissioners on 
August 27. 1993. 

CHAPTER 18 
ENVIRONIVIENTAL HEALTH 

SUBCHAPTER 18C - WATER SUPPLIES 

SECTION .0100 - PROTECTION OF 
PUBLIC WATER SUTPLIES 

.0102 DEFINITIONS 

(a) The definitions contained in G.S. 130A-2 
and G.S. 130A-313 are hereby adopted incorporat- 
ed by reference ifl — acoordance — with — G.S. 
15QB 1 4 (0) including any subsequent amendments 
and editions. Copies of this material may be 
obtained from the Department of Environment. 
Health, and Natural Resources. Division of Envi- 



ronmental Health 
P.O. Box 29536, 



, Public Water Supply Section. 
Raleish, North Carolina 27626- 



0536 at no charge . 

(b) The definitions contained in 40 C.F.R. 141 .2 
are hereby adopt e d incorporated by reference m 
accordance with G.S. — 150B 1 4 (o) including any 
subsequent amendments and editions except the 
following definitions are not adopted: 



(1) "Disinfection", 

(2) "Maximum containment level", 

(3) "Person", 

(4) "Public Water System", and 

(5) "Supplier of water". 

This material is available for inspection at the 
Department of Environment. Health, and Natural 
Resources. Division of Environmental Health. 
1330 Saint Mary's Street. Raleigh. North Caroli- 
na. Non-members may obtain copies from the 
American Water Works Association. Information 
Services. 6666 West Quincy Avenue. Denver. 
Colorado 80235 at a cost of fifteen dollars 
($15.00) U2 to 20 pages and thirty cents ($0.30) 
per page for each additional page . 

(c) In addition to the definitions adopted by 
reference, the following definitions shall apply to 
this Subchapter: 

(1) "Act" means the North Carolina Drink- 
ing Water Act. 

(2) "Class I reservoir" shall mean a reser- 
voir from which water flows by gravity 
or is pumped directly to a treatment 
plant or to a small intervening storage 
basin and thence to a treatment plant. 

(3) "Class II reservoir" shall mean a reser- 
voir from which the water flows by 
gravity or is pumped to a Class I reser- 
voir prior to final entrance to a water 
treatment plant. 

(4) "Class III reservoir" is a large im- 
poundment used for electric power 
generation, flood control, and similar 
purposes, and which also serves as a 
source of raw water for a community 
water system. 

(5) "Cross-connection" shall mean: 

(A) any physical connection between a 
potable water supply system and any 
other piping system, sewer fixture, 
container, or device, whereby water 
or other liquids, mixtures, or sub- 
stances may flow into or enter the 
potable water supply system; 

(B) any potable water supply outlet which 
is submerged or is designed or intend- 
ed to be submerged in non-potable 
water or in any source of contamina- 
tion or; 

(C) an air gap, providing a space between 
the potable water pipe outlet and the 
flood level rim of a receiving vessel 
of less than twice the diameter of the 
potable water pipe. 

(6) "Community Water System intake" 



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September 15, 1993 



PROPOSED RULES 



shall mean the structure at the head of 
a conduit into which water is diverted 
from a stream or reservoir for transmis- 
sion to water treatment facilities. 

(7) "Disinfection" means a process which 
inactivates pathogenic organisms in 
water. 

(8) "Fecal Colifbrm" means bacteria con- 
sistently found in the intestine of man 
and other warm blooded animals which 
are not normally disease producing but 
serve as indicators of recent fecal con- 
tamination. They are members of the 
Family Enterobacteriaceae, Genus 
Escherichia, Species Coli. 

(9) "Mobile Home Park" means a site or 
tract of land where spaces are provided 
for lease or rental only to mobile home 
occupants. 

(10) "Mobile home subdivision" means a 
subdivided site or tract of land in which 
lots are sold for use by mobile home 
occupants. 

(9) (1 1) "Non-potable water supply" shall 
mean waters not approved for drinking 
or other household uses. 

fW) (12) "Potable water supply" shall mean 
water which is approved for drinking or 
other household uses. 

f4-4-) (13) "Raw water" m e ans shall mean 
surface water or groundwater which 
because of bacteriological quality, 
chemical quality, turbidity, color, or 
mineral content makes it unsatisfactory 
as a source for a community water 
system without treatment. 

{4-3) (14) "Raw water reservoir" m e ans 
shall mean a natural or artificial im- 
poundment used for the primary pur- 
pose of storing raw water to be subse- 
quently treated for use as a source for 
a community water system. 

(15) "Service connection" shall mean a 
piped connection from a water main for 
the purpose of conveying water to a 
building or onto a premise for human 
use. A piped connection from a water 
main to a travel trailer space, camping 
space or marina slip is not a service 
connection. 

(16) "Water supply product" means any 
chemical or substance added to a public 
water system in conjunction with a 
treatment technique or material used in 
construction of a public water system . 



The term includes any material used in 
the manufacture of public water system 
components, appurtenances, any pipe, 
storage tank, valve or fixture which 
comes in contact with water intended 
for use in a public water system. 

Authority G.S. 130A-311 through 130A-327; P.L. 
93-523; 40 C.F.R. 141.2. 

SECTION .0200 - LOCATION OF SOURCES 
OF PUBLIC WATER SUPPLIES 

,0201 SURFACE SUPPLIES FOR PUBLIC 
WATER SYSTEMS 

(a) A surface supply may be used for a commu- 
nity or a non-transient, non-community water 
system with disinfection and without filtration if it 
complies with the provisions of this Section and 
Rule .2005 of this Subchapter . 

(b) Such water supply shall be derived from 
uninhabited wooded areas. 

(c) The entire watershed shall be either owned 
or controlled by the person supplying the water or 
be under the control of the federal or state govern- 
ment; however, no such new water supply shall be 
created except where the water system owner shall 
own in its entirety the watershed from which the 
water will be obtained. 

(d) The water after disinfection shall be of 
potable quality as determined by bacteriological 
and chemical tests performed by a certified labora- 
tory. The presence of contaminants shall not 
exceed the limits set forth in Section .1500 of this 
Subchapter. 

(e) The water source shall have an WS-I classifi- 
cation as established by the Environmental Man- 
agement Commission and shall meet the quality 
standards for that classification. 



Statutory Authority 
P.L. 93-523. 



G.S. 130A-315; 130A-318; 



.0202 REMOVAL OF DISSOLVED MATTER 
AND SUSPENDED MATTER 

Any surface water which is to receive treatment 
for removal of dissolved matter or suspended 
matter in order to be used for a community public 
water system shall be obtained from a source 
which meets the WS-I, WS-II, er WS-III, WS-IV 
or WS-V stream classification standards established 
by the Environmental Management Commission 
and shall be prop e rly protected from objectionable 
sources of pollution as determined by a sanitary 
survey of the watershed made by an authorized 



8:12 



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September 15, 1993 1115 



PROPOSED RULES 



representative of the Department. The source 
supply shall be sufficient in capacity to satisfy the 
anticipated needs of the users for the period of 
design. 



Statutory Authority G. S. 
P.L. 93-523. 



130A-315: I30A-318: 



.0203 PUBLIC WELL WATER SUPPLIES 

Any site or sites for any water supply well to be 
used as a community or non-transient, non- 
community v-ater system shall be investigated by 
an authorized representative of the Division of 
Environmental Health. Approval by the Division 
is required in addition to any approval or permit 
issued by any other state agency. The site shall 
meet the following requirements for approval: 

(1) The well shall be located on a lot so that 
the area within 100 feet of the well shall 
be owned or controlled by the person 
supplying the water. The supplier of 
water shall be able to protect the v. ell site 
from potential sources of pollution and to 
construct landscape features for drainage 
and diversion of pollution. When the 
supplier of u-ater is unable to locate 
water from any other approved source or 
when an existing well is temporarily out 
of operation, a representative of the 
Division may approve a smaller well lot 
area. 

(2) The well shall be located at l e ast 100 f e et 
from any s e w e r or oth e r potential sources 
ef — pollution — unl e ss — tfee — sewe? — is 
construct e d of materials and joints that 
arc equis'al e nt to wat e r main standards, in 
which cas e th e s e w e r shall be at least 50 
fe e t from the well, so the movement of 
contaminants from potential sources of 
pollution shall not interfere with the 
quality of the drinking water source. The 
minimum horizontal separation between 
the well and potential sources of pollution 
shall be as follows: 

(a) 100 feet from any sanitary sewage 
disposal system . sewer, or a sewer pipe 
unless the sewer js constructed of 
material and joints that are equi\alent to 
v.'ater main standards, in which case the 
sev.er pipe shall be at least 50 feet from 
the well; 

(b) 200 feet from a subsurface sanitan,' 
sev.age treatment and disposal s\'stem 
designed for 3000 or more gallons of 
wastev.ater a day flows, unless h. [s 









m 
m 

m 

ill 



m 

l£l 



determined that the well water source 

utilizes a confined aquifer; 

500 feet from a septage disposal site; 

100 feet from buildings, mobile homes. 

permanent structures, animal houses or 

lots, or cultivated areas to which 

chemicals are applied; 

100 feet from surface water; 



100 feet from a chemical or petroleum 
fuel underground storage tank v^'ith 
secondary containment; 
500 feet from a chemical or petroleum 
fuel underground storage tank without 
secondary' containment; 
500 feet from the boundary of a ground 
water contamination area; 
500 feet from a sanitary landfill or non- 
permitted non-hazardous solid waste 
disposal site; 

1000 feet from a hazardous waste 
disposal site or otherwise in a location 
which conflicts with the North Carolina 
Hazardous Waste Management Rules; 
300 feet from a cemetery or burial 
ground; and 

100 feet from any other potential source 
of pollution. 
The Department may require greater 
separation distances or impose other 
protective measures when necessary to 
protect the well from pollution; the 
Department shall consider as follows: 
The hazard or health risk associated 
with the source of pollution; 
The proximity of the potential source to 
the Vv'ell; 

The type of material, facility or 
circumstance that poses the source or 
potential source of pollution; 
The volume or size of the source or 
potential source of pollution; 
Hydrogeological features of the site 
which could affect the movement of 
contaminants to the source water; 



The efi'ect which well operation might 
have on the movement of 
contamination; and 

The feasibility of providing additional 
separation distances or protective 
measures. 
(4) The site shall be graded or sloped so 
that surface water is diverted away from 
the well head . The site shall not be 
subject to flooding^ Groundwater under 
the direct influence of surface water shall 



1116 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



not be approved as a source unless there 
is no other approvable site available . 

Statutory Authority G.S. 130A-315; 130A-318; 
P.L. 93-523. 

SECTION .0300 - SUBMISSION OF PLANS: 
SPECIFICATIONS: AND REPORTS 

.0301 APPLICABILITY: PRIOR NOTICE 

(a) All persons, including units of local 
government, intending to construct, alter, or 
expand a community or non-transient, non- 
community water system shall give written notice 
thereof, including submission of applicable plans, 
specifications and engineering reports, to the 
Division of Environmental Health, as required by 
the rules of this Section. A non-community water 
system using surface water or ground water under 
the direct influence of surface water shall be 
subject to the provisions of this Rule. An adjacent 
water system shall not be subject to the provisions 
of this Rule unless the adjacent water system is 
constructed, altered or expanded on or after July 
31, 1987. 

(b) All reports, plans and specifications shall be 
submitted to the Division at least 30 days prior to 
the date upon which action by the Division is 
desired. 

(c) If revisions to the plans or specifications are 
necessary, the engineer who prepared them will be 
notified. Revised plans and specifications will 
constitute a resubmittal and additional time will be 
required for review. 

Statutory Authority G.S. 130A-315; 130A-317; 
PL. 93-523. 

.0302 PLANS 

(a) Procedure Applicable to all Projects, 
Extensions, or Changes. All plans, specifications 
or other data intended for submission to the 
Division of Environmental Health , in oomplianoe 
with — th« — statut e s — oov o ring community — wat e r 
syst e ms, shall be submitted in triplicate for review 
by the Public Water Supply Section, Division of 
Environmental Health, P.O. Box 29536, Raleigh, 
North Carolina 27626-0536. 

(b) Plans for Community Water Systems . Plans 
should consist of legible prints having black, blue, 
or brown lines on a white background suitable for 
microfilming. The plans shall not be more than 36 
inches wide and 48 inches long. 

Statutory Authority G.S. 130A-315; 130A-317: 



P.L. 93-523. 

.0303 SUBMISSIONS REQUIRED BY 

ENGINEER AND WATER SUPPLIER 

Detailed plans and specifications for community 
wat e r syst e ms shall be prepared by a professional 
engineer licensed to practice in the State of North 
Carolina. The plans shall bear an imprint of the 
registration seal of the engineer. Upon completion 
of the construction or modification ef — the 
community wat e r syst e m , the water supplier shall 
submit a statement signed by a registered 
professional engineer and aflixed with his 
professional engineering seal stating that 
construction was completed in accordance with 
approved plans and specifications and revised only 
in accordance with the provisions of Rule .0306 of 
this Section. The statement shall be based upon 
adequate observations during and upon completion 
of construction by the engineer or a representative 
of the engineer's oflSce who is under the 
engineer's supervision. 

Statutory Authority G.S. 130A-315; 130A-317; 
PL. 93-523. 

.0305 APPROVAL OF PLANS NECESSARY 
BEFORE CONTRACTING 

(a) No construction of community wat e r syst e ms 
shall be undertaken, and no contract for 
construction, alteration, or installation ef 
community wat e r syst e ms shall be entered into 
prior to approval of plans and specifications by the 
Department. 

(b) Units of local government which have an 
adopted water system extension policy, upon 
submission to and approval of a copy of their 
policy by the Department, may be excluded from 
the requirements of submitting plans and 
specifications for water main extensions, and that 
would not have adverse effect upon the existing 
system supply or pressure, provided the following 
requirements are met: 

(1) Plans and specifications for all such 
extensions shall be prepared by or 
under the direct supervision of an 
engineer licensed to practice in the 
State of North Carolina. 

(2) All plans shall be approved by the units 
of local government engineering 
department or its consulting engineers 
prior to the commencement of 
construction. 

(3) The Department shall have approved 
the extension policy submitted by the 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1117 



PROPOSED RULES 



unit of local government prior to 
construction commencing. 

(4) The extension policy submitted for 
review and approval by the Department 
shall provide for establishing 
ownership, operation and maintenance 
of water system extensions, and shall 
constitute prior notice of proposed 
construction. 

(5) Where design is to be based on a local 
government's standard specifications in 
lieu of written separate specifications 
for each extension project, the standard 
specifications shall have been 
previously approved by the Department. 

(6) The local government shall have 
obtained from the Department a letter 
stating they have met the 
aforementioned requirement and are 
excluded from the requirement for 
submitting detailed plans and 
specifications for each minor extension 
in keeping with the intent of this Rule. 

(7) Where such minor additions or 
extensions have been made an annual 
up-to-date plan of the entire system 
shall be submitted for review and 
approval by the Division. 



Statutory Authority G. S. 
P.L. 93-523. 



130A-315; 130A-317: 



.0307 ENGINEER'S REPORT 

(a) The owner, when required, shall submit to 
the Division, an engineering report in duplicate 
covering the basic factors and principles 
considered in planning of the project. 

(b) Such engineering reports shall be required 
for projects involving new community water 
systems, modification of existing community water 
system systems , development or modification of 
surface water sources and other community water 
system projects requiring significant engineering. 

(c) Before preparation of the engineering report, 
the consulting engineer may wish to consult with 
the office or field staffs of the Division of 
Environmental Health concerning the proposed 
source of supply, treatment methods, and 
alternatives. 

Statuton- Authority G.S. 130A-3I5; 130A-317: 
P.L. 93-523. 

.0308 TYPE AND FORM OF EXfflBITS 

(a) Engineer's Report. The engineer's report 



(including any preliminary plans) shall contain the 
following information where applicable: 

(1) description of any existing water system 
related to the project; 

(2) identification of the municipality, 
community, er area^ or facility to be 
served by the proposed water system; 

(3) the name and address of the owner; 

(4) a description of the nature of the 
establishments and of the area to be 
served by the proposed water system; 

(5) provisions for future extension or 
expansion of the water system; 

(6) a projection of future water demand or 
requirements for service; 

(7) any alternate plans for meeting the 
water supply requirements of the area; 

(8) financial considerations of the project 
including: 

(A) any alternate plans; 

(B) costs of integral units; 

(C) total costs; 

(D) operating expenses; and 

(E) methods of financing costs of 
construction, operation and 
maintenance; 

(9) population records and trends, present 
and anticipated future water demands, 
present and future yield of source or 
sources of water supply; 

(10) character of source or sources of water 
supply, including: 

(A) hydrological data; 

(B) stream flow rates; 

(C) chemical, mineral, bacteriological, 
and physical qualities; and 

(D) location and nature of sources of 
pollution; and 

(11) proposed water treatment processes 
including: 

criteria and basis of design of units, 
methods or procedures used in 
arriving at recommendations, and 
reasons or justifications for any 
deviations from conventional or 
indicated process or method, 
(b) Plans. Plans for water supply systems shall 
consist of the following: 

(1) title information including the follow- 
ing: 

(A) name of the city, town, board, com- 
mission or other owner for whom the 
plans were prepared; 

(B) the locality of the project; 

(C) the general title of the set of drawings 



(A) 
(B) 

(C) 



1118 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



and prints; 

(D) the specific title of each sheet; 

(E) the date; and 

(F) the scales used; 

(2) a preliminary plat plan or map showing 
the location of proposed sources of 
water supply; 

(3) a general map of the entire water sys- 
tem showing layout and all pertinent 
topographic features; 

(4) detail map of source or sources of 
water supply; 

(5) layout and detail plans for intakes, 
dams, reservoirs, elevated storage 
tanks, standpipes, pumping stations, 
treatment plants, transmission pipelines, 
distribution mains, valves, and appurte- 
nances and their relation to any existing 
water system, and the location of all 
known existing structures or installa- 
tions and natural barriers that might 
interfere with the proposed construc- 
tion; and 

(6) the north point. 

(c) Specifications. Complete detailed specifica- 
tions for materials, equipment, workmanship, test 
procedures and specified test results shall accom- 
pany the plans. The specifications shall include, 
where applicable: 

(1) the design and number of chemical 
feeders, mixing devices, flocculators, 
pumps, motors, pipes, valves, filter 
media, filter controls, laboratory facili- 
ties and equipment, and water quality 
control equipment and devices; 

(2) provision for continuing with minimum 
interruption the operation of existing 
water supply facilities during construc- 
tion of additional facilities; 

(3) safety devices and equipment; and 

(4) procedure for disinfection of tanks, 
basins, filters, wells and pipes. 

(d) A supplier of water which has submitted a 
local water supply plan in accordance with G.S. 
143-355(1) shall also provide a copy to the Divi- 
sion of Environmental Health. 

Statutory Authority G.S. 130A-315; 130A-317; 
P.L. 93-523. 

SECTION .0400 - WATER SUPPLY DESIGN 
CRITERIA 

.0401 MINIMUM REQUIREMENTS 

The design criteria given in this Section are the 



minimum requirements for approval of plans and 
specifications of community water syst e ms by the 
Division of Environmental Health, Department of 
Environment, Health, and Natural Resources. The 
Department provides additional guidelinoo supple- 
mental criteria for design of water systems in 15A 
NCAC 18C .0500 - .1000. 

Statutory Authority G.S. 130A-315; 130A-317; 
PL. 93-523. 

.0402 WATER SUPPLY WELLS 

(a) Well Construction. The construction of 
water supply wells shall conform to well construc- 
tion regulations and standards of the Division of 
Environmental Management, N.C. Department of 
Environment, Health, and Natural Resources. 

(b) Upper Terminal of Well. The well casing 
shall neither terminate below ground nor in a pit. 
The pump pedestal for above ground pumps of 
every water supply well shall project not less than 
six inches above the concrete floor of the well 
house, or the concrete slab surrounding the well. 
The well casing shall project at least one inch 
above the pump pedestal. For submersible pumps 
the casing shall project at least six inches above 
the concrete floor or slab surrounding the well 
head. 

(c) Sanitary Seal. The upper terminal of the 
well casing shall be sealed watertight with the 
exception of a vent pipe or vent tube having a 
downward-directed, screened opening. 

(d) Concrete Slab or Well House Floor. Every 
water supply well shall have a continuous bond 
concrete slab or well house concrete floor extend- 
ing at least three feet horizontally around the 
outside of the well casing. Minimum thickness for 
the concrete slab or floor shall be four inches. 

(e) Sample Tap and Waste Discharge Pipe. 
Faucets or spigots shall be provided for sampling 
both raw water prior to treatment and treated water 
prior to delivery to the first customer. Sample 
spigots shall not be threaded for hose connection. 
Threaded hose bibs shall be equipped with anti- 
siphon devices. A water sample tap and piping 
arrangement for discharge of water to waste shall 
be provided. 

(f) Physical Security and Well Protection. A 
water supply well shall be secured against unautho- 
rized access and protected from the weather. One 
of the following structures shall be provided: 

(1 ) Well house. A well house shall be 
constructed as follows: 
(A) Structures shall comply with applica- 
ble provisions of state and local build- 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1119 



PROPOSED RULES 



ing codes; 

(B) Drainage shall be provided by floor 
drain, wall drain, or slope to door; 

(C) Access into the structure shall be a 
doorway with minimum dimensions of 
36 inches wide and 80 inches high; 
and 

(D) The structure shall have adequate 
space for the use and maintenance of 
the piping and appurtenances. If 
treatment is provided at the well, the 
provisions of Rule ■0404(a) of this 
Section shall app ly. 

(2) Prefabricated structures. A prefabricat- 
ed structure shall be constructed as 
follows: 

(A) A well-head cover shall be hinged and 
constructed so that it can be lifted by 
one person; 

(B) A locking mechanism shall be provid- 
ed; and 

(C) Permanent fastening to the slab (such 
as with bolts) shall not be permitted. 

(3) Fencing and temperature protection. 
Fencing and temperature protection 
shall be constructed as follows: 

The fence height shall be a minimum 
of six feet; 

The fence shall be constructed of 
chain link with locked access; 

fence shall enclose the well; 



IB] 
IE} 



m Ig) 
(1) 



(2) 



(3) 



The 

hydropneumatic tank, and associated 
equipment; 

Access shall be provided for adequate 
maintenance and operation; and 
The well, piping, treatment equip- 
ment, and electrical controls shall be 
protected against freezing. Wrap ping 
with insulation is acceptable for ap- 
purtenances such as the air vent, 
meter, valves, and sample taps pro- 
vided they are visible and accessible- 
Insulation shall be jacketed. 
Yield: 

Wells shall be tested for yield and 
drawdown. A report or log of at least 
a 24-hour drawdown test to determine 
yield shall be submitted to the Division 
of Environmental Health for each well. 
Wells shall be located so that the draw- 
down of any well will not interfere with 
the required yield of another well. 
The combined yield of all wells of a 
water system shall provide in 12 hours 
pumping time the average daily demand 



as determined in Subparagraph (f)(7) 
Rule .0409 of this Section . 

(4) The capacity of the permanent pump to 
be installed in each well shall not ex- 
ceed the yield of the well as determined 
by the drawdown test. 

(5) A residential community water system 
using well water as its source of supply 
and designed to serve 50 or more r e si 
d e noes or connections shall provide at 
least two wells. A travel trailer park or 
campground designed to serve 100 or 
more connections shall provide at least 
two wells. In lieu of a second well, 
another approved water supply source 
may be accepted. 

(6) A totalizing meter shall be installed in 
the piping system from each well. 

(7) Th e w e ll or w e lls s e rving a mobile 

home park shall be capable of supply 

ing an av e rage daily d e mand of 250 

gallons p e r day p e r oonnootion. The 

w e ll or wells serving reoidcnocs shall 

be capable of supplying an average 

daily demand of 4 (X) gallons p e r day 

per conn e ction. 

{g) {h} Initial Disinfection of Water Supply 

Well. All new wells, and wells that have been 

repaired or reconditioned shall be cleaned of 

foreign substances such as soil, grease, and oil, 

and then shall be disinfected. A representative 

sample or samples of the water (free of chlorine) 

shall be collected and submitted to an approved a 

certified laboratory for bacteriological analyses. 

After disinfection the water supply shall not be 

placed into service until bacteriological test results 

of representative water samples analyzed in aft 

approv e d a certified laboratory are found to be 

satisfactory. 

0») li) Initial Chemical Analyses. A representa- 
tive sample of water from every new water supply 
well shall be collected and submitted for chemical 
analyses to the Division of Laboratory Services or 
to a certified laboratory approved by th e Division . 
The results of the analysis must be satisfactory 
before the well is placed into service. 

{i) (j} Continuous Disinfection. Equipment 
designed for continuous application of chlorine or 
hypochlorite solution or some other approved and 
equally efficient disinfectant shall be provided for 
all well water supplies introduced on or after 
January 1, 1972. Equipment for determining 
residual chlorine concentration in the water shall 
be specified. 



1120 



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September 15, 1993 



PROPOSED RULES 



Statutory Authority G.S. 130A-315; 130A-317; 
P.L. 93-523. 

.0403 SURFACE WATER FACILITIES 

(a) Unimpounded Stream. Both the minimum 
daily flow of record of the stream and the estimat- 
ed minimum flow calculated from rainfall and 
run-ofl" shall exceed the maximum daily draft for 
which the water treatment plant is designed with 
due consideration given to requirements for future 
expansion of the treatment plant. The Department 
may approve a water plant capacity greater than 
the minimum daily flow of record of the stream 
when rules of other government agencies will not 
be violated. The maximum allowable system 
expansion shall be based on the minimum daily 
flow of record of the stream . 

(b) Pre-settling Reservoirs. Construction of a 
pre-settling or pre-treatment reservoir shall be 
required where excessive bacterial concentrations 
or wide and rapid variations in turbidity or chemi- 
cal qualities occur. 

(c) Impoundments. Raw water storage capacity 
shall be sufficient to reasonably satisfy the de- 
signed water supply demand during periods of 
drought. 

(d) Clearing of Land for Impoundment. The 
area in and around the proposed impoundment of 
class I and class II reservoirs shall be cleared as 
follows: 

(1) The area from normal full level to five 
feet below the normal full level of the 
impoundment shall be cleared and 
grubbed of all vegetation and shall be 
kept cleared until the reservoir is filled. 
Secondary growth shall be removed 
prior to flooding. A margin of at least 
50 f ee t around th e impoundm e nt shall 
be owned or controll e d by the wat e r 
suppli e r. 

(2) The entire area below the five foot 
water depth shall be cleared and shall 
be kept cleared of all growth of less 
than six inches in diameter until the 
reservoir is filled. Stumps greater than 
six inches in diameter may be cut ofl^ at 
ground level. 

(3) All brush, trees, and stumps shall be 
burned or removed from the proposed 
reservoir. 

(e) Existing Impoundments. Existing impound- 
ments may be approved as raw water sources as 
follows: 

• iXX The requirements of Paragraph (c) of 
this Rule, and Section .0200 of this 



Subchapter shall be met; 

£2} A class I or class II reservoir shall meet 
the requirements of Section . 1200 of 
this Subchapter; and 

£3} The supplier of water shall have an 
engineer and other qualified consultants 
as needed conduct a study of the im- 
poundment and provide the Department 
information to determine whether the 
requirements of this Subchapter are 
met. The study shall include as fol- 
lows: 

(A) Plans and specifications of the im- 
pounding structure; 

(B) Information concerning clearing of the 
land for impoundment as provided in 
Paragraph (d) of this Rule; 

(C) Information concerning sources of 
pollution on the watershed; 

(D) Documentation of control by the 
supplier of water of the impoundment 
and 50 foot margin around the im- 
poundment; 

(E) Information concerning the quality of 
the water and sediments which could 
cause water quality fluctuations such 
as lake stratification, turnover and 
algae bloom; and 

(F) Other information necessary to show 
the proposed source will meet the 
requirements of this Subchapter. 

(f) A margin of at least 50 feet around the 
impoundment shall be owned or controlled by the 
water supplier. 

(e) (g) Intakes, Pumps, Treatment Units, and 
Equipment. Raw water intakes, pumps, treatment 
units and equipment shall be designed to provide 
water of potable quality meeting the water quality 
requirements stated in Section .1500 of this Sub- 
chapter. 

Statutory Authority G.S. 130A-315: 130A-317; 
P.L. 93-523. 

.0404 WATER TREATMENT FACILITIES 

(a) Physical Security and Facility Protection. 
Treatment equipment and chemicals shall be 
secured against unauthorized access and shall be 
protected against the weather as follows: 

(1) Structures shall comply with provisions 
of state and local building codes; 

(2) Drainage shall be provided by floor 
drain, wall drain, or slope to door; 

(3) Access to the structure shall be a door- 
way with minimum dimensions of 36 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1121 



PROPOSED RULES 



inches wide and 80 inches high or 
larger. The doorway shall be large 
enough to accommodate installation or 
removal of equipment; and 
(4) The structure shall have space to facili- 
tate operation and maintenance of treat- 
ment equipment, storage of chemicals, 
required piping and appurtenances, 
electrical controls, and laboratory test- 
ing. Space shall be provided for antici- 
pated future equipment. 
(h) Mixing and Dispersion of Chemicals. 
Provisions shall be made for ad e quat e mixing and 
dispersion of chlorine and other chemicals applied 
to the water. There shall be provided a minimum 
of 20 minutes chlorine contact time prior to pump- 
ing the water to the distribution system. All 
facilities treating surface water or ground water 
influenced by surface water shall comply with the 
disinfection requirements in Section .2002 of this 
Subchapter. 
fb) (c} Chemical Feed Machines 
(1) Durable chemical feed machines de- 
signed for adjustable accurate control of 
feed rates shall be installed for applica- 
tion of all chemicals necessary for 
appropriate treatment of the water. 
Chemical pretreatment using coagulant 
chemicals is required prior to filtration 
by granular filter media. Sufficient 
stand-by units to assure uninterrupted 
operation of the treatment processes 
shall be provided. Continuous chemical 
application must be protected from 
electrical circuit interruption which 



could result in overfeed. 



(2) 



£3] 



{^ id) 
(1) 



Chemical feed lines from the feeders to 
the points of application shall be of 
durable material, adequate in size, 
corrosion resistant, easily accessible for 
cleaning and protected against freezing. 
Excessive length shall be avoided and 
the number of bends reduced to a mini- 
mum. 

Piping and appurtenances shall be 
constructed of suitable material for the 
chemical being added and the specific 
application. 

Disinfection Equipment 
Equipment designed for application of 
chlorine, or some other approved, 
equally efficient disinfectant shall be 
provided. Stand-by units shall be pro- 
vided. The plans and specifications 
shall describe the equipment in detail. 



(2) Chlorinators shall be installed in tightly 
constructed, above ground rooms with 
adequate mechanical ventilation to the 
outside air. The capacity of exhaust 
fans shall be sufficient to discharge all 
air in the rooms every 30 seconds to 1 
minute. The fans or their suction ducts 
shall be located not more than eight 
inches above floor level. Provisions for 
entrance of fresh air shall be made. 
The point of discharge shall be so 
located as not to contaminate the air in 
any building or inhabited areas. Electri- 
cal switches for operation of fans shall 
be located outside the chlorinator 
rooms. Rooms used for storage of 
chlorine cylinders shall be designed as 
described above. 
^ {e} Safety Breathing Apparatus. Em e rg e ncy 
Self-contained emergency breathing equipment for 
operators shall be stored outside rooms where 
chlorine is used or stored. 

(e) £f} Meters and Gauges. Meters and gauges, 
including raw and finished water meters, shall be 
installed to indicate and record water flow entering 
the treatment plant and water pumped or conducted 
to the distribution system. 

4f) i^ Prevention of Backflow and Back- 
Siphonage. Submerged inlets and interconnections 
whereby non-potable water, or water of question- 
able quality, or other liquids may be siphoned or 
forced into or otherwise allowed to enter the 
finished water supply shall not be permitted. 

(f) £hj Chemical Storage. Separate space for 
storing at least 30 days supply of chemicals shall 
be provided. A separate room or partitioned space 
shall be provided for storage of dry fluoride 
chemicals or liquid fluoride chemicals in portable 
containers. 

fh) ii] Laboratory. Adequate space, equipment, 
and supplies shall be provided for daily, routine 
chemical and bacteriological tests. A layout of 
laboratory furniture and equipment shall be includ- 
ed in the plans. 

^ (j} Toilet Facilities. Adequate toilet facili- 
ties shall be provided for the plant personnel. 

Statutory Authority G.S. 130A-3I5; 130A-317; 
P.L. 93-523. 

.0405 STORAGE OF FINISHED WATER 

(a) Ground Level Storage 
(1) Water Ground Storage Tank. Finished 
water ground storage tanks shall be 
provided with a light-proof and 



1122 



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September 15, 1993 



PROPOSED RULES 



insect-proof cover of concrete, steel or 
other material approved by the 
Division. The construction joints 
between side walls and the covers of 
concrete tanks or reservoirs shall be 
above ground level and above flood 
level; except that clearwells constructed 
below filters may be excepted from this 
requirement when total design, 
including waterproof joints, gives equal 
protection. 

(2) Access Manholes. The access 
manholes for finished water storage 
tanks or reservoirs shall be framed at 
least four inches above the tank or 
reservoir covers at the opening and 
shall be fitted with solid covers of 
durable materials that overlap the 
framed openings and extend down 
around the frames at least two inches. 
The covers for the openings shall be 
hinged at one side and fitted with a 
locking device. 

(3) Tanks or Reservoirs. The tanks or 
reservoirs shall have vents with 
screened, downward directed openings. 
The vent and screen shall be of 
corrosion resistant, durable material. 

(4) Overflow. The overflow pipes for 
storage tanks or reservoirs shall not be 
connected directly to sewers or storm 
drains. Screens or other devices to 
prevent access by rodents, insects, etc. 
should be provided in the overflow 
pipe. 

(5) Inlets and Outlets. Water supply inlets 
and outlets of storage tanks and 
reservoirs shall be located and designed 
to provide adequate circulation of the 
water. Baffles shall be constructed 
where necessary to provide thorough 
circulation of the water. 

(6) Drain Valves. All tanks and reservoirs 
shall be equipped with drain valves. 

(b) Elevated Storage Tanks 
(1) Standards. The specifications for 
elevated tanks, stand-pipes, towers, 
paints, coatings and other appurtenances 
shall meet the appropriate 
ANSI/ AW WA Standards D 100-7^ 84 
and D 10I-53 (R86) , and D 102 6 4 of 
the American Water Works Associa- 
tion, Inc., which is adopt e d are hereby 
incorporated by reference including any 
subsequent amendments and editions. 



This material is available for inspection 
at the Department of Environment, 
Health, and Natural Resources, Divi- 
sion of Environmental Health, 1330 
Saint Mary's Street, Raleigh. North 
Carolina. in aooordance with G.S. 

150B 1 4 (o) ef approv e d e qual 

Btandardg. — Copi e s of AWWA standards 
are available from Non-members may 
obtain copies from the American Water 
Works Association, 6666 W. Quincy 
Avenue, Denver, Colorado 80235 at a 
cost of eighteen dollars and fifty cents 
($18.50) for D 100-84 and nine dollars 
($9.00) for D 101-53(R86) . Copi es ar e 
availabl e for public insp e ction at th e 
principal addre ss of th e Division. 

(2) Elevation of Storage Tanks. The eleva- 
tion of storage tanks shall be sufficient 
to produce a designed minimum distri- 
bution system pressure of 20 pounds 
per square inch at peak ffow. 

(3) Drain. Elevated storage tanks shall be 
equipped with drain valves. 

(c) Hydropneumatic Storage Tanks (Pressure 
Tanks) 

(1) Use of Pressure Tanks. Where well 
yields and pumping capacities are suffi- 
cient, hydropneumatic (pressure) tanks 
may be used to control pumps, stabilize 
pressures and provide a minimum of 
storage. Pressure tanks shall have the 
capacity to maintain a minimum pres- 
sure of 30 pounds per square inch 
throughout periods of peak flow. Pres- 
sure tanks shall not be considered ac- 
ceptable for meeting total storage re- 
quirements for water systems of over 
300 connections, except as provided in 
Rule .0405(d) of this Section. 

(2) Corrosion Control. Pressure tanks shall 
be galvanized after fabrication, provid- 
ed with an approved liner or coated in 
accordance with AWWA — Standard — D 
102 6 4 of the Am e rican Wat e r Work s 
j\3gooiation. Inc., which is adopt e d by 
r e fer e nc e — m — accordanc e — with — G^Sr 
15QB 1 4 (c) or approv e d e qual standard. 
Copies — ef — AWWA — standards — are 
availabl e — from — the — American — Wat e r 
Works j\soooiation, — 6666 W. — Quincy 
Avenu e , — Denver, — Colorado — 8 0235. 

Copies are — available — fef — public 

insp e ction at the principal addr es s of 
the — Division Rule .1537 of this 



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PROPOSED RULES 



Subchapter . 

(3) Required Parts. Pressure tanks shall 
have access manholes, bottom drains, 
pressure gauges, and properly sized 
safety and vacuum relief valves. 

(4) Controls. Automatic pressure, 
start-stop controls for operation of 
pumps shall be provided. 

(5) Hydropneumatic Storage Tanks. 
Hydropneumatic storage tanks shall 
conform to the construction 
requirements for pressure vessels 
adopted by the North Carolina 
Department of Labor and codified in 13 
NCAC 13 which is adopted by 
reference in accordance with G.S. 
1 SOB- 14(c). Copies of the rules are 
available from the Boiler and Pressure 
Vessel Division, North Carolina 
Department of Labor, 214 West Jones 
Street, Raleigh, N.C. 27603. 

("6) Appurtenances to hydropneumatic 
storage tanks such as valves, drains, 
gauges, sight tubes, safety devices, air- 
water volume controls, and chemical 
feed lines shall be protected against 
freezing. 
(d) High Yield Aquifers 

(1) Equipment. In lieu of providing 
elevated storage for systems over 300 
connections in areas where aquifers are 
known to produce high yields, i.e., 
400-500 gpm from an eight-inch well, 
a system of extra well pumping 
capacity, auxiliary power generating 
equipment, hydropneumatic tanks, 
controls, alarms and monitoring 
systems may be provided. The design 
and installation of such system shall 
assure that reliable, continuous service 
is provided. 

(2) Auxiliary Power. Such a system shall 
have an adequate number of wells 
equipped with sufficient pumping 
capacity so that the required flow rate 
can be maintained with the single 
largest capacity well and pump out of 
operation. Auxiliary' power generating 
equipment shall be provided for each 
well sufficient to operate the pump, 
lights, controls, chemical feeders, 
alarms and other electrical equipment as 
may be necessary. 

(3) Pump Control. Hydropneumatic tanks 
designed in accordance with Paragraph 



(c) of this Rule and Section .0800 of 
this Subchapter shall be provided to 
maintain pressure and control the pump 
operation. 
(4) Alarm System. An alarm system shall 
be provided which will send a visual or 
audible signal to a constantly monitored 
location so that the water system 
operator will be advised of a primary 
power failure. 



Statutory Authority G. S. 
P.L. 93-523. 



130A-315: 130A-317: 



.0407 ELECTRICAL SYSTEMS 

Electrical wiring and equipment shall comply 
with applicable provisions of the national, state, 
and local electrical codes. Protection against 
moisture and overheating shall be provided. 



Statutory Authority 
P.L. 93-523. 



G.S. 130A-315: 130A-317: 



1124 



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PROPOSED RULES 



.0409 SERVICE CONNECTIONS 

(a) Local Water Supply Plan. Units of local government which are operating under a local water supply 
plan in accordance with G.S. 143-355(1) shall not be limited in the number of service connections. 

£bj No local water supply plan. A public water system which does not have a local water supply plan 
as stated in Paragraph (a) of this Rule shall limit its number of service connections as follows: 

(1) A public water system serving one type of service connection shall meet the minimum daily flow 
requirements specified in Table J_i 



Table J_i Minimum Daily Flow Requirements 

Type of Service Connection Daily Flow for Design 

Residential 400 gallon/connection 

Mobile Home Parks 250 gallon/connection 

Campgrounds and Travel Trailer Parks 120 gallon/space 

Marina 10 gallon/boat slip 

Marina with bathhouse 30 gallon/boat slip 

Rest Homes and Nursing Homes 

with laundry 120 gallon/bed 

without laundry 60 gallon/bed 

Schools J5 gal Ion/ student 

Day Care Facilities 15 gallon/student 

Construction, work, or summer camps 60 gallon/person 

Business, office, factory (exclusive of industrial use) 

without showers 25 gallons/person/shift 

with showers 35 gallon/person/shift 

Hospitals 300 gallon/bed 



(2) A public water system serving dilTerent types of service connections shall meet the maximum 
daily demand calculated as follows: 

(A) Where records of the previous year are available that reflect daily usage, the average of the two 
highest consecutive days of record of the water treated shall be the value used to determine if 
there is capacity to serve additional service connections (unusual events such as massive line 
breaks or line flushings shall not be considered). 

(B) Where complete daily records of water treated are not available, the public water system shall 
multiply the daily average use based on the amount of water treated during the previous year 
of record by the appropriate factor to determine maximum daily demand, as follows: 

{i} A system serving a population of 10. (XX) or less shall multiply the daily average use by 2.5; 

or 
(ii) A system serving a population greater than 10.000 shall multiply the daily average use by 

2.0. 

Statutory Authority G.S. 130A-315: 103A-317; P.L. 93-523. 



SECTION .0500 - SUPPLEMENTAL DESIGN 
CRITERIA 

.0501 PURPOSE 

For the protection of the public health, and 
pursuant to authority granted by Article 10 of 
Chapter 130A of the General Statutes of North 
Carolina, the Commission for Health Services 
hereby adopts the following rules (15A NCAC 
18C .0500 through JOOO) governing th e location 
of sources of supply of community' water systems, 
th e d e sign and construction of community water 
syst e ms, th e op e ration of oommuoity water sys 



tems, — and the prot e ction of community water 
s yst e m s a^ supplemental design criteria for approv- 
al of plans and specifications . 

Statutory Authority G.S. 130A-315: 130A-317; 
RL. 93-523. 

.0502 DESIGN GUIDELINES 

Th es e de s ign guidelines ar e int e nd e d to supple 
ment the mandatory criteria e stablish e d in the rules 
providing for the prot e ction of community water 
s y s tems (15A NCAC — 18C) as adopt e d by th e 
Commission for H e alth S e rvic e s, and ar e to b e 



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PROPOSED RULES 



used a s rcoommend e d guid e lin e s in the preparation 
of plans and opooifioations for oommunity wat e r 
systems. 

Community and non-transient, non-community 
water systems and non-community water systems 
using surface water or ground water under the 
influence of surface water shall comply with these 
supplemental design criteria unless alternate design 
proposals are approved by the Department. The 
Department shall consider the following factors ]n 
approving an alternate design: 

(1) The potential health risk of using the 
alternate design; 

(2) The need for deviation from the supple- 
mental design criteria; 

(3) The degree of deviation from the supple- 
mental design criteria; and 

(4) The capability of the alternate design to 
meet the maximum contaminant levels, 
treatment techniques and other require- 
ments of this Subchapter. 

Statutory Authority G.S. 130A-315; 130A-317; 
P.L. 93-523. 

SECTION .0700 - SURFACE WATER 
TREATMENT FACILITIES 

.0703 MECHANICAL FLOCCULATION 

(a) Basin Inlet and Outlet. The design of inlets 
and outlets of flocculation basins shall prevent 
short circuiting of the water and destruction or 
deterioration of the floe. 

(b) Detention Period. The flocculation basins 
should have a theoretical detention period of not 
less than 20 minutes. 

(c) Agitator Control. The agitators of floccula- 
tion basins shall be equipped with variable speed 
controls. 

(d) Paddles. Peripheral speed and paddle 
configuration shall be designed to obtain optimum 
velocity gradient. 

Statutory Authority G.S. 130A-315; 130A-317; 
RL. 93-523. 

.0708 GRAVITY FILTERS 

(a) Filtration Rates. The standard rate of filtra- 
tion for a single media filter shall be two gallons 
per minute per square foot. Higher filtration rates 
up to four gallons per minute per square foot may 
be approved for dual media or multi-media filters. 
Filtration rates in excess of four gallons per minute 
per square foot may be approved subject to pilot 
plant or plant scale demonstrations conducted in 



accordance with Rule .0714 of this Section. 

(b) Wash Water Rate. The backwash rate of 
flow shall be designed to theoretically expand the 
filter media 50 percent. 

(c) Rate Control Devices. Rate control equip- 
ment shall be provided to control or regulate the 
filtration rate and the backwash rate. If declining 
rate filtration is to be utilized, orifice plates shall 
be installed on each filter effluent pipe to control 
maximum filtration rates. 

(d) Surface Washers. Filter beds shall be 
equipped with a revolving or fixed system of 
nozzles designed for uniform wat e rj e t agitation of 
the entire beds. 

(e) Gauges and Flow Indicators. Gauges or 
meters shall be installed to indicate the rate of 
filtration, the loss of head, and backwash rate for 
every filter. 

(f) Filter Media: 

(1) Filter Sand. Filter sand shall be clean 
silica sand having: 
{44 (A) an effective size of 0.35 mm to 
0.55 mm, 

(3) £B] a uniformity coefficient of not 
more than 1 .70, 

{^ (C) a dust content (passing 150 mesh 
tyler) less than 0.5 percent, and 

(4) (D) a depth of at least 24 inches and 
generally not more than 30 inches. 

■(g) £2} Anthracite Filter Media. If anthra- 
cite coal is used as a single filter media, 
it shall have an effective size of 0.35 
mm to 0.55 mm and a uniformity coef- 
ficient of 1 .70 or less. Minimum depth 
of the media shall be 24 inches. 
^ £3} Dual Media or Multi-media Filters. 
Dual media and mixed media filter beds 
may have a wider range of gradation 
than single media beds. Particle sizes 
may range from 0.15 mm to 1.2 mm 
within the beds. Influent water quality 
shall be considered in specifying parti- 
cle sizes of mixed media beds. The 
minimum depth of the filter media 
s hould shall be 24 inches, 
(i) [gl Supporting Media and Underdrain 
System. The underdrain system and layers of 
gravel or other media supporting the filter media 
shall be designed to provide uniform filtration and 
uniform backwash throughout the filter media. 

{^ (h) Wash Water Troughs Elevation. The 
elevation of the bottom of the wash water troughs 
for new installations shall be above the maximum 
level of the expanded media during washing at the 
normal design wash water rate. The elevation of 



1126 



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PROPOSED RULES 



the top of the wash water troughs shall provide a 
two-inch freeboard above the expanded media at 
the maximum rate of wash. 

(k) (i} Turbidity Monitoring. Turbidimeters 
employing the nephelometric method, or measure- 
ment of the intensity of scattered light, should 
shall be provided for the continuous determination 
of the turbidities of filtered water from each filter 
unit. 

^ (]] Sampling Tap. A tap shall be installed 
for convenient sampling of the effluent from each 
filter. 

(k) Multiple Filter Units. Two or more filter 
units shall be provided such that the average daily 
demand can be satisfied at the approved filtration 
rate with one filter removed from service. 

{]} Structural Design. Filters shall have vertical 
walls with no protrusions or curvature. Floors of 
filter rooms shall be designed to prevent flooding 
or spillage into filters through provisions of over- 
flow drainage and a minimum of four inch curbs 
around the filters. 

(m) Filter to Waste. All filters shall have 
provisions for filtering to waste with backflow 
prevention. 

(n) Backwash Pump. Backwash capacity to 
ensure thorough cleaning of the filters shall be 
provided. 

Statutory Authority G.S. 130A-315; 130A-317: 
P.L. 93-523. 

.0710 DIRECT FILTRATION 

Treatment plants which use direct filtration may 
be approved to treat high quality source water. An 
engineering report shall be submitted to the De- 
partment and shall include data and information to 
substantiate source water quality characteristics as 
follows: 
(1) The source water shall have constant low 
levels of microbiological organisms, 
turbidity, suspended matter and other 
contaminants, based on maximum con- 
taminant levels set in this Subchapter; 
The source water shall be derived from 



12] 
i3J 



WS-1 or WS-II watersheds; and 

A pilot plant study shall be conducted in 

accordance with Rule .0714 of this Sec- 

tion. 



Statutory Authority G.S. 130A-315; 130A-317; 
PL. 93-523. 

.0711 PACKAGE PLANTS 

(a) Package plants which use conventional 



m 

141 
151 



i61 



filtration treatment may be approved to treat high 
quality source waters. An engineering report shall 
be submitted to the Department and shall include 
data to substantiate the water quality characteristics 
as follows: 

(I) The source waters shall have low levels 
of microorganisms, turbidity, suspended 
matter and other contaminants, based 
on the maximum contaminant levels set 
in this Subchapter; 

Raw water quality parameters shall not 
fluctuate; 

The watershed shall be free of pollution 
sources and potential for contaminant 
spills; 

The flocculation process shall have a 
minimum of 20 minutes theoretical 
detention time; 

The sedimentation compartment shall 
utilize tube, settlers, plates or equiva- 
lent settling enhancement mechanisms 
and have a minimum 30 minutes deten- 
tion time; and 

The filter media shall be a minimum of 
24 inches in depth and consist of dual 
or multi-media, 
(b) Where a package plant incorporates floccula- 
tion and sedimentation into one process and com- 
plies with Subparagraph (a)(1), (2), and (6) of this 
Rule, a pilot plant study shall be conducted on the 
proposed raw water supply in accordance with 
Rule .0714 of this Section. 

Statutory Authority G.S 130A-315; 130A-317: 
PL. 93-523. 

.0712 PRESSURE FILTERS 

Pressure filters shall not be used in treatment of 
surface waters. Pressure filters may be approved 
for treatment of groundwater under the influence 
of surface water under the following conditions: 
(1) Design standards for gravity filters in 
Rule .0708 of this Section shall apply; 
Overall plant design shall comply with 
Rule .0404 of this Subchapter; 
Special design or operational features or 
modifications shall be provided when 
needed due to water quality or design of 
the proposed filter; and 
When necessary to demonstrate eflFective 
treatment of the water source by the 
proposed filter, a pilot plant study shall 
be conducted in accordance with Rule 
.0714 of this Section. 



£2J 
ill 

14} 



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September 15, 1993 1127 



PROPOSED RULES 



Statutory Authority G.S. 130A-315; 130A-317; 
P.L. 93-523. 

.0713 OTHER FILTRATION 
TECHNOLOGIES 

A public water system may propose an alterna- 
tive filtration technology as provided in Rule .2003 
of this Subchapter. If the Department determines 
that the proposed plant employs treatment tech- 
niques that are consistent with this Subchapter, a 
pilot study shall be conducted in accordance with 
Rule .0714 of this Section. If the pilot study 
demonstrates to the Department that the proposed 
plant can consistently produce water which com- 
plies with all requirements of this Subchapter, 
detailed engineering plans and specifications for 
the proposed plant and appurtenances shall be 
presented to the Department for review and ap- 
proval prior to construction. 

Statutory Authority G.S. 130A-315: 130A-317: 
PL. 93-523. 

.0714 PILOT PLANT STLDIES 

(a) A pilot plant study proposal shall be submit- 
ted to the Department for approval before the 
study is conducted. The following conditions shall 
apply: 

(1) An engineering report shall describe the 
proposed study and shall include the 
information and data to iustifs' use of 
the particular plant to treat the source 
water; 

(2) The proposed plant shall employ treat- 
ment techniques that are consistent with 
this Subchapter; 

(3) Tht pilot plant shall be of the same 
design and operation as the proposed 
plant; 

(4) A protocol for conducting the study 
shall be submitted which includes the 
duration, testing procedures, reporting 
procedures, plant scale and other fac- 
tors which aff"ect the proposed plant 
operation; and 

(5) The study shall be conducted over a 
time sufficient to treat all worst case 
source water conditions expected 
through the year. 

(b) Pilot plant finished water shall not be intro- 
duced to a public wat er system. 

(c) When the proposed plant or pilot plant has 
been tested extensively under worst case conditions 
on similar water and achieved 2.0 log removal of 
Giardia cysts and a maximum of 0.5 N'TU turbidi- 



ty levels 95 percent of the time in filtered effluent, 
the particular model plant may be proposed with- 
out on-site testing. 

(d) The pilot plant shall comp ly with the provi- 
sions of Section .0200 of this Subchapter. 

Statutory Authority G.S. 130A-315; 130A-317; 
PL. 93-523. 

.0715 OTHER DESIGN STANDARDS 

In evaluation of water systems or water system 
design features not addressed in this Rule, the 
Department shall apply standards from the Ameri- 
can Water Works Association or Recommended 
Standards for Water Works of _1_0 states and Ontar- 
io. A copy is available for inspection at the Public 
Water Supply Section. 1330 St. Mary's Street, 
Raleigh. North Carolina. 

Statutory Authority G.S 130A-315; 130A-317; 
PL. 93-523. 

SECTION .0800 - H\T)ROPNEUMATIC 
STORAGE TANKS 

.0802 CAPACITIES: DETERMINING PEAK 
DEMAND 

There are charts available from the Plan Review 
Branch. Public Water Supply Section. Division of 
Environmental Health, which shall be used to 
determine the peak demand for residential commu- 
nitieSi and mobile home parks^ campgrounds, and 
non-transient, non-community water systems . 

Statutory Authority G.S. 130A-315; 130A-317: 
PL. 93-523. 

.0803 CAPACITIES: DETERMINING 
TOTAL VOLUME 

The total volume of the pressure tank shall be 
calculated by using the principle of Boyle's Law or 
by using the curves indicating air-water volume 
relationships available from the Plan Review 
Branch, Public Water Supply Section, Division of 
Environmental Health. The total volume (gallons) 
shall be not less than 25 times the number of 
connections or 500 gallons, whichever is greater 
for a mobile home park. In the case of a residen- 
tial community (community water system) the total 
volume shall not be less than 40 times the number 
of connections or 500 gallons, whichever is great- 
er. In the case of campgrounds, the total volume 
shall not be less than 10 times the number of 
connections or 5(X) gallons, whichever is greater. 



1128 



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PROPOSED RULES 



Statutory Authority G. S. 
P.L. 93-523. 



130A-315; 130A-317; 



.0804 CAPACITIES: GROUND STORAGE 
PLUS HYDROPNEUMATIC TA>fKS 

When ground level storage tanks and 
high-service pumps are to be used, 
hydropneumatic tanks shall be sized in relation to 
peak demand and the high-service pump capacity 
in aooordanoo with — the proo e dur e s outlin e d in 
■0 8 01 to .0803 of thio Section . 



Statutory Authority G. S. 
PL. 93-523. 



130A-315; 130A-317; 



.0805 CAPACITIES: ELEVATED STORAGE 

(a) Where feasible, elevated storage capacity 
should meet the requirements of Fire Insurance 
Rating Bureau. 

(b) The minimum capacity of elevated storage in 
a small municipality should shall be 75,000 gallons 
or a one-day supply, whichever is greater. 

(c) The elevated storage for a large municipality 
should shall be sufficient to minimize the effect of 
fluctuating demand plus provide a reasonable 
reserve for fire protection. The combined elevated 
and ground storage of finished water should shall 
be at least one day's supply. 

(d) In the case of community and non-transient, 
non-communitv water systems, the combined 
elevated and ground storage of the finished water 
shall be at least one-half days supply except that 
the provisions of Paragraphs (a), fb), and (c) of 
this Rule shall apply when these storage 
requirements are greater. 

Statutory Authority G. S. 
P.L. 93-523. 



130A-315: 130A-317; 



SECTION .1000 - DISINFECTION OF 
WATER SUPPLY S\ STEMS 

.1002 DISINFECTION OF WELLS 

(a) After water supply wells have been cleaned 
of foreign substances, including sediment, grease 
and oil, the wells shall be disinfected by the 
addition of chlorine solution in concentrations 
sufficient to produce a chlorine residual of at least 
50 milligrams per liter (or ppm) in the entire water 
column within the well casing. 

(b) The chlorine solution shall remain in the 
well for a period of 24 hours. Then th e The well 
shall then be pumped until the water is free of 
chlorine. 

(c) A representative sample or samples of the 



water shall be collected and analyzed by a certified 
laboratory . If bacteriological tests indicate that the 
water is satisfactory, the well may be placed in 
service. 



Statutory Authority G. S. 
PL. 93-523. 



130A-315; 130A-317; 



.1004 DISINFECTION OF FILTERS 

(a) After filters have been thoroughly 
backwashed to remove dust, silt and other foreign 
matter the entire filter (including filter media, 
supporting material and underdrain system) shall 
be disinfected by application of a chlorine solution 
having a concentration of at least 50 milligrams 
per liter (or ppm). 

(b) The solution shall be dispersed throughout 
the filter bed and remain in contact for a period of 
at least 24 hours. 

(c) For treatment equipment that cannot tolerate 
chlorine. alternate disinfection procedures ^ 
recommended by the equipment manufacturer shall 
be reviewed by the Department. 

Statutory Authority G.S 130A-315; 1 30A-3 ] 7: P L. 
93-523. 

SECTION .1200 - PROTECTION OF 
FILTERED WATER SUPPLIES 

.1207 ANIMALS IN RESERVOIR 

The watering, washing or wallowing of any 
horses, mules, cattle, or domestic animals shall not 
be permitted in or along the margin of any class I 
or class II reservoir. Domestic or farm animals 
shall be restrained from access to an area within 
50 feet of the reservoir at normal full level unless 
each animal is under direct supervision and each 
activity involving animals is under the control and 
supervision of the supplier of water. The supplier 
of water shall ensure such activities do not 
adversely affect the drinking water supply . 



Statutory Authority 
PL. 93-523. 



G.S 130A-315: 130A-320: 



.1209 UNTREATED DOMESTIC SEWAGE 
OR INDUSTRIAL WASTES 

No treated or untreated domestic sewage, treated 
or untreated industrial waste or by-products shall 
be stored on the watershed of or discharged into 
any public water supply reservoir or stream 
tributary to that reservoir whose waters are 
classified as WS-I. No untreated domestic sewage 
or industrial waste by-products shall be discharged 



8:12 



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September 15, 1993 1129 



PROPOSED RULES 



into any public water supply reservoir or stream 
classified as WS-II, ef WS-III^ WS-IV, or WS-V . 

No hazardous waste, industrial by-products, 
treated or untreated domestic sewage shall be 
stored in the watershed of a Class I or Class II 
water supply reservoir, without the approval of the 
Division. No hazardous waste or industrial 
by-products shall be stored in the watershed of a 
Gtess WS-IL or Class WS-III, WS-IV, or WS-V 
stream unless precautions are taken to prevent its 
being spilled into or otherwise entering the raw 
water supply. No wastewater treatment plant 
effluent shall be discharged into any public water 
supply reservoir or stream classified as WS-II_i er 
WS-III^ WS-IV. or WS-V without the approval of 
the Division. 



Statutory Authority 
P.L. 93-523. 



.1211 



G.S. 130A-315; 130A-320: 



GROUND ABSORPTION SEWAGE 
COLLECTION: TREATMENT/DISP 
SYSTEMS 

(a) No facility, including but not limited to a 
residence, mobile home, mobile home park, 
multi-unit building or dwelling, place of business 
or place of public assembly on a lot located on a 
watershed of a class I or class II reservoir or on 
the watershed of the portion of a stream classified 
as WS-I, WS-IL ©f WS-III^ WS-IV, or WS-V 
extending from a class I reservoir to a downstream 
intake of a water purification plant shall use a 
ground absorption sewage disposal system unless 
all of the following criteria are met: 

(1) The lot includes at least 40.000 square 
feet, except as provided in 
Subparagraphs (a)(2) and (a)(3); 

(2) The lot shall include enough total area 
to equal an average of 40.000 square 
feet per residential dwelling unit for a 
multiple unit residential building or 
mobile home park; 

(3) The lot shall include enough total area 
to equal an average of 40,000 square 
feet for each business within a multiple 
unit place of business or place of public 
assembly; 

(4) The lot for any business or place of 
public assembly for which the 
anticipated wastewater generated 
exceeds 1250 gallons per day will 
require an additional 40,000 square feet 
of area -fef qct each additional 1250 
gallons per day or portion thereof. The 
anticipated wastewater generated shall 



(3) 
(4) 



(5) 



be determined in accordance with 15 A 
NCAC 18A .1949; 

(5) The lot size requirement shall be 
determined by excluding streets; and 

(6) Compliance with all other applicable 
state and local rules and laws is 
achieved. 

(b) The Director of the Division or his 
authorized representative, shall have authority, 
when special local factors permit or require it in 
order to protect the public health adequately and to 
ensure proper health and sanitary conditions, to 
increase the lot size requirements in particular 
cases upon a determination based on any of the 
following factors: 

(1) size of the reservoirs; 

(2) quantities and characteristics of the 
wastes; 

type of business, use, or activity; 
coverage of lot area by structures, 
parking lots and other improvements; 
and 
type and location of the water supply. 

(c) The requirements of this Rule do not apply 
to those portions of a water supply reservoir 
watershed which are drained by class B or class C 
streams. These requirements become effective 
whenever funds have been appropriated either for 
purchase of land or for construction of a class I or 
class II reservoir. 

(d) The requirements of this Rule do not apply 
to water supply reservoir watersheds which are 
protected by the Water Supply Watershed 
Protection Act G.S. 143-214.5. 

Statutory Authority G.S 130A-315; 130A-320; 
P.L. 93-523. 

SECTION .1300 - VARIANCES AND 
EXEMPTIONS 

.1301 OPERATION REQUIRING 
DISINFECTION ONLY 

(a) Operator in Charge. The operator in charge 
of a community public surface water system 
requiring disinfection shall be capable of 
computing chlorine dosages and other chemical 
dosages that may be applied to the water. The 
operator shall be familiar with the entire water 
system, including pipelines, chlorinators and other 
appurtenances pertaining to the operation of the 
entire system. TTie operator shall hold a valid 
certificate issued by the North Carolina Water 
Treatment Facility Operators Certification Board. 

(b) Tests; Reports. The operator shall make 



1130 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



adequate residual chlorine tests and other 
applicable tests at least daily and shall report the 
results of the tests to the I^iblic Water Supply 
Section in a monthly report which shall includ e 
pertinent information r e quir e d on forms provided 
by the Department. Copies of this report form 
indicating the required information may be 
obtained from the Public Water Supply Section. A 
copy of each monthly report shall be submitted by 
the tenth day of the following month to the Public 
Water Supply Section. 

Statutory Authority G.S. 130A-315; 90A-29; P.L. 
93-523. 

.1302 OPERATION OF FILTERED PUBLIC 
WATER SYSTEMS 

(a) Operator in Charge. The person in 
responsible charge of operation of a community 
public water system filtration plant where raw 
water is obtained from a class WS-I, WS-II^ ef 
WS-III^ WS-IV. or WS-V stream as classified by 
the Division of environm e ntal — managem e nt 
Environmental Management and removal of 
dissolved matter or suspended matter is required 
shall hold an appropriate valid certificate issued by 
the North Carolina Water Treatment Facility 
Operators Certification Board. 

(b) Tests; Forms. Adequate bacteriological and 
chemical tests and analysis of the water shall be 
made at least daily when the plant is operating and 
shall be reported to the Public Water Supply 
Section, in a monthly report which shall include 
p e rtin e nt information r e quir e d on forms provided 
by the Department. Copies of report forms 
indicating the required information may be 
obtained from the Public Water Supply Section. A 
copy of each monthly report shall be submitted by 
the tenth day of the following month to the Public 
Water Supply Section. 

(c) Operation. An operator shall be on duty at 
the treatment facility whenever the treatment 
facility is in operation. 

Statutory Authority G.S. 130A-315; 90A-29; P.L. 
93-523. 

.1303 OPERATION OF PUBLIC WATER 
SYSTEM WELLS 

(a) Operator in Charge. The operator of a 
community and non-transient, non-community 
water system well shall be capable of computing 
chlorine dosages and other chemical dosages which 
are applied to the water when such treatment is 
required. The operator shall be familiar with the 



entire water system, including pipelines, pumps, 
chlorinators, and other appurtenances pertaining to 
the operation of the entire water system. TTie 
operator shall hold a valid certificate issued by the 
North Carolina Water Treatment Facility Operators 
Certification Board. 

(b) Tests; Forms. When application of chlorine 
and other chemicals are required, the operator 
shall make required residual chlorine tests and 
other tests at least daily and shall report his results 
to the Public Water Supply Section, in a monthly 
report which shall includ e pertin e nt information 
r e quir e d on forms provided by the Division De- 
partment . Copies of this report form indicating 
the required information may be obtained from the 
Public Water Supply Section. A copy of each 
monthly report shall be submitted by the tenth day 
of the following month to the Public Water Supply 
Section. 

Statutory Authority G.S. 130A-315; 90A-29; PL. 
93-523. 

SECTION .1400 - FLUORIDATION OF 
PUBLIC WATER SUPPLIES 

.1406 CONTROL OF TREATMENT 
PROCESS 

(a) The treatment process shall result in the 
adjustment of fluoride ion (F) in the treated water 
to 1 .0 mg/liter. 

(b) A water treatment plant operator, having 
qualifications acceptable to the controlling health 
agencies, shall conduct the necessary chemical 
analyses and supervise application of the fluoride. 

(c) An adequate number of samples shall be 
collected and analyzed from points before and after 
fluoridation and from one or more points in the 
distribution system. TTie minimum number of 
control tests and the number of check samples to 
be collected and submitted to the Division of 
Laboratory Services will be determined by the 
controlling health agencies in each instance. 

(d) The fluoride content of the water shall be 
determined in accordance with either the procedure 
given in the latest edition of "Standard Methods 
for the Examination of Water and Wastewater" 
which is adopted by reference in accordance with 
G.S. 1 SOB- 14(c) or other procedures approved by 
the Secretary. 

(e) Accurate records of the amount of fluoride 
applied to the water and the results of all fluoride 
analyses shall be recorded on forms approved by 
the Department and submitted to the Department 
on or b e for e the 15th day of the following month 



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September 15, 1993 



1131 



PROPOSED RULES 



weekly . 

(f) The quality of the fluoride chemical applied 
to the water shall be approved by the Department. 
TTie manufacturer shall submit a certified copy of 
the chemical analysis of the product ofl'ered for 
sale. Test for the purity of the chemical shall 
include the U.S. Pharmacopoeia tests for heavy 
metals which is adopted in accordance with G.S. 
1 508- 14(c). 

Statutory Authority G.S. 130A-316. 

SECTION .1500 - WATER QUALITY 
STANDARDS 

. 1 537 DRINKING WATER ADDITIVE S 

(a) The standards set forth in American National 
Standards Institute/NSF International, codified at 
ANSI/NSF Standard 60 and ANSl/NSF Standard 
61. are hereby incorporated by reference including 
any subsequent amendments and editions. This 
material is available for inspection at the Depart- 
ment of Environment. Health, and Natural Re- 
sources. Division of Environmental Health. 1330 
Saint Mary's Street. Raleigh. North Carolina. 
Copies of ANSI/NSF 60: Drinking Water Treat- 
ment Chemicals - Health Effects or ANSI/NSF 61 : 
Drinking Water System Components ; Health 
Effects may be obtained at a cost of forty-five 
dollars ($45.00) each from NSF International. 
P.O. Box 130140. Ann Arbor. Michigan 48113- 
0140. 



:jc:ic:ic3){j!c:jc:jc%:{c 






(b) A water supp ly product used in a public 
water system shall meet the standards incorporated 
by reference in Paragraph (a) of this Rule. A 
product certified by an organization having a third- 
party certification program accredited by the 
American National Standards Institute to test and 
certify such products is acceptable for use in a 
public water system. 

(c) A supplier of water shall maintain a list of 
all water supply products used in a public water 
system for inspection by the department. Prior to 
using a product not previously listed, a supplier of 
water shall either determine the product is certified 
as required by Paragraph (b) of this Rule or notify 
the department of the type, name and manufacturer 
of a product. 

(d) A su pplier of water shall not willfully 
introduce or permit the introduction of a water 
supply product into a public water system which 
does not meet the requirements of this Rule. 

Statutory Authority G.S. 103A-315: P.L. 93-523. 



iSotice is hereby given in accordance with G.S. 
150B-21.2 that EHNR - Commission for Health 
Services intends to amend rule cited as ISA NCAC 
19A .0206. 

1 he proposed effective date of this action is 
January 4, 1994. 

1 he public hearing will be conducted at 10:00 
a.m. on October 15, 1993 at the Groundfloor 
Hearing Room, Archdale Building. 512 N. Salis- 
bury Street, Raleigh, N. C. 

tveason for Proposed Action: To extend the 
deadline by which the designated staff member in 
each organization shall have successfully complet- 
ed a course in infection control approved by the 
Department. 

(comment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P.O. Box 629, 
Raleigh, NC 27602-0629. All written comments 
must be received by October 20, 1993. Persons 
who wish to speak at the hearing should contact 
John P Barkley at (919)733-4618. Persons who 
call in advance of the hearing will be given 
priority on the speaker's list. Oral presentation 
lengths may be limited depending on the number of 
people that wish to speak at the public hearing. 
Only persons who have made comments at a public 
hearing or who have submitted written comments 
will be allowed to speak at the Commission 
meeting. Comments made at the Commission 
meeting must either clarify previous comments or 
proposed changes from staff pursuant to comments 
made during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS, GROUPS, BUSINESSES, 
ASSOCIAnONS. IN^nTUTlONS OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS. WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED RULES. THE 



1132 



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NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



COMMISSION MAY MAKE CHANGES TO THE 
RULES AT THE COMMISSION MEETING IF THE 
CHANGES COMPLY WITH GS 1508-21.2(0- 

CHAPTER 19 
HEALTH: EPIDEMIOLOGY 

SUBCHAPTER 19A - COMMUNICABLE 
DISEASE CONTROL 

SECTION .0200 - CONTROL MEASURES 
FOR COMMUMCABLE DISEASES 

.0206 INFECTION CONTROL - HEALTH 
CARE SETTINGS 

(a) The following definitions shall apply 
throughout this Rule: 

(1) "Health care organization" means 
hospital; clinic; physician, dentist, 
podiatrist, or chiropractic office; home 
health agency; nursing home; local 
health department; community health 
center; mental health agency; hospice; 
ambulatory surgical center; urgent care 
center; emergency room; or any other 
health care organization that provides 
clinical care. 

(2) "Invasive procedure" means entry into 
tissues, cavities, or organs or repair of 
traumatic injuries. The term includes 
but is not limited to the use of needles 
to puncture skin, vaginal and cesarean 
deliveries, surgery, and dental 
procedures during which bleeding 
occurs or the potential for bleeding 
exists. 

(b) Health care workers, emergency responders, 
and funeral service personnel shall follow blood 
and body fluid precautions with all patients. 

(c) Health care workers who have exudative 
lesions or weeping dermatitis shall refrain from 
handling patient care equipment and devices used 
in performing invasive procedures and from all 
direct patient care that involves the potential for 
contact of the patient, equipment, or devices with 
the lesion or dermatitis until the condition 
resolves. 

(d) All equipment used to puncture skin, mucous 
membranes, or other tissues in medical, dental, or 
other settings must be disposed of in accordance 
with 15A NCAC 13B after use or sterilized prior 
to reuse. 

(e) In order to prevent transmission of HIV and 
hepatitis B from health care workers to patients, 
each health care organization that performs 



invasive procedures shall implement a written 
infection control policy by July 1, 1993. The 
health care organization shall ensure that health 
care workers in its employ or who have staflF 
privileges are trained in the principles of infection 
control and the practices required by the policy; 
require and monitor compliance with the policy; 
and update the policy as needed to prevent 
transmission of HIV and hepatitis B from health 
care workers to patients. TTie health care 
organization shall designate a staff member to 
direct these activities. By January — h — 199 4 , 
September _L 1994 the designated staflF member in 
each health care organization shall have 
successfully completed a course in infection 
control approved by the Department. The course 
shall address: 

(1) Epidemiologic principles of infectious 
disease; 

(2) Principles and practice of asepsis; 

(3) Sterilization, disinfection, and sanita- 
tion; 

(4) Universal blood and body fluid precau- 
tions; 

(5) Engineering controls to reduce the risk 
of sharp injuries; 

(6) Disposal of sharps; and 

(7) Techniques which reduce the risk of 
sharp injuries to health care workers. 

(f) The infection control policy required by this 
Rule shall address the following components that 
are necessary to prevent transmission of HIV and 
hepatitis B from infected health care workers to 
patients: 

(1) Sterilization and disinfection, including 
a schedule for maintenance and micro- 
biologic monitoring of equipment; the 
policy shall require documentation of 
maintenance and monitoring; 

(2) Sanitation of rooms and equipment, 
including cleaning procedures, agents, 
and schedules; 

(3) Accessibility of infection control devic- 
es and supplies; 

(4) Procedures to be followed in imple- 
menting 15A NCAC 19A .0202(4) and 
.0203(b)(3) when a health care provider 
or a patient has an exposure to blood or 
other body fluids of another person in a 
manner that poses a significant risk of 
transmission of HIV or hepatitis B. 

Statutory Authority GS I30A-144; 130A-145. 



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September 15, 1993 



1133 



PROPOSED RULES 



l\otice is hereby given in accordance with G.S. 
150B-21.2 that EHNR - Commission for Health 
Services intends to amend rules cited as 15A 
NCAC 19A .0401. .0406. .0502. 

1 he proposed effective date of this action is 
January 4. 1994. 

1 he public hearing will be conducted at 10:00 
a.m. on October 15. 1993 at the Groundfloor 
Hearing Room, Archdale Building, 512 N. Salis- 
bury Street, Raleigh, N. C. 

Jxeason for Proposed Action: 

15A NCAC 19A.0401 - This amendment adds 

three requirements to the current immunization 

schedule: 

1. a second dose of measles vaccine 
before entering school (K-1), 

2. a second dose of measles vaccine 
before entering college, and 

3. a three dose series of hepatitis B 
vaccine for all infants. 

It removes one restriction by allowing children 
over three years of age to receive a dose of He- 
mophilus influenzae, b (Hib) vaccine. 

All three changes are current recommendations of 
the Centers for Disease Control and Prexention 
(CDC), Immunizations Practices Advisory Commit- 
tee (ACIP). The Inwiunization Branch as been 
requested to make these changes by the NC Pediat- 
ric and Medical Societies, but until now the re- 
sources have not been available. 

The requirement of these immunizations will 
compliment the Immunization Branch's implemen- 
tation of universal distribution of vaccine (to all 
pro\iders for all children) since G.S. 130A-433 
allows only the distribution of "covered vaccine" 
(a vaccine administered pursuant to the require- 
ments of G.S 130A-152). 

The addition of MMR2 and hepatitis B vaccine and 
the inclusion of 3-5 year olds in the Hib vaccine 
schedule were included in calculations presented to 
Fiscal Management for expansion budget consider- 
ations. They represent vaccines that legislators 
expect wll be distributed to private physicians for 
administration to children seen in their offices. 



ISA NCAC 19A .0406 - Prior to the ratification of 
HB 452 (G.S. 130A-153). many attorneys, health 
care providers and facilities have used G.S. 130A- 
143, that strictly regulates the confidentiality of 
medical records to dictate policies regarding the 
sharing of immunization records. This strict 
interpretation has created a major barrier for 
providers and parents, who see or present a child 
for his/her shots but do not know the child's 
immunization status, even though an immunization 
certificate was issued when the immunization was 
administered. Frequently such information would 
not be released via telephone. Rather the previous 
provider of immunizations would require a written 
request or a parent's in-person request for re- 
cords. 

To remove the strict confidentiality constraints on 
sharing itnmunization records among providers 
(physicians, local health departments, etc.), G.S. 
130A-153 was passed, and the Commission has 
been directed to define other person(s) who may 
need access to immunization information, in part, 
such as name, date and dosage administered 
matched with child identifiers, or in whole. 
Schools (K-1 2): day-care facilities: colleges; 
universities; residential and day camps: hospitals, 
for patients: and employers are institutions that 
need to know immunization information. 

G.S. 130A-152 requires e\'ery child to be immu- 
nized against diphtheria, tetanus, whooping cough, 
poliomyelitis, red measles, mumps, rubella and a 
type of influenza that causes meningitis. G.S. 
130A-155 requires a certificate of immunization, 
indicating that a child has received the required 
immunizations, be presented to a school (K-1 2), 
day care center, college and university prior to 
entry. If a child is not properly immunized and 
does not obtain the required vaccines, suspension 
is required. 

15A NCAC 19A .0502 - To comply with G.S 
130A - 152 and G.S. 130A - 433 and the legisla- 
tive intent of the 1993 General Assembly for the 
purchase of vaccines for all North Carolina pro- 
viders for all North Carolina children. 15A NCAC 
19A .0502 is proposed for amendment. The 
changes to the rule include: 

1. the elimination of an income 

qualifier, thus allowing the distri- 
bution of required vaccines to all 
providers for all children (univer- 
sal vaccine distribution), as funds 



1134 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



permit; 

2. removal of the requirement for 
local health departments to redis- 
tribute vaccines to private provid- 
ers, thus placing the responsibili- 
ty for distribution of state-sup- 
plied vaccine, to the expanded 
provider comnmnity, on the Im- 
munization Branch; 

3. setting the "reasonable fee " that 
a provider can charge for an 
immunization visit; 

4. the provider 's agreement to waive 
the administration fee if a patient 
is unable to pay thus further 
ensuring that an opportunity to 
immunize a child is not missed 
because of referral to the health 
department or delay until the 
family can raise the money; and 

5. expanding the flexibility regarding 
signing of separate vaccine 
Important Irformation Statements, 
thus eliminating some paper 
required for filing in the 
patients 's chart. 

North Carolina's preschool age-appropriate 
immunization rates are abysmally low, at 58. 7 
percent. A partial explanation for the 

underimmunizption of preschoolers has to do with 
the decrease of private providers' participation in 
the immunization effort, over the past decade. 
Private providers have multiple opportunities to 
immunize many of the children in the state. 
However, over 90 percent of North Carolina 
physicians who participated in a fall of 1992 study 
of North Carolina Private Physician 's 
Immunization Practices indicate that they refer, at 
least some, of their patients to the local health 
department for their shots. A large percentage of 
the responding physicians responded that their 
reason for referral was because "the parent said 
they could not afford "or" the physician was 
concerned that the family could not afford the 
immunization. " The referred child may ne\'er 
make it to the health department, thus remaining 
susceptible to vaccine-preventable diseases. 

More families will be able to get their children's 
shots at physicians ' offices when the vaccine cost 
barrier is removed as it will be when vaccine is 
supplied free by the State. By setting a standard 
administration fee, physicians will charge all 
parents the same amount and will have to forfeit 



the fee if a parent cannot afford it. 

The fee $16. 48/per visit (same amount whether one 
or four injections) is the same fee reimbursed to 
local health departments by Medicaid. It is based 
on a cost study performed by UNC-CH, School of 
Public Health. It is higher than a 1992 CDC 
vaccine administration cost study that indicated 
$10.34/visit, but this study is 18 months old and 
leaves the physicians no room for price mark-up. 

(comment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P.O. Box 629, 
Raleigh, NC 27602-0629. All written comments 
must be received by October 20, 1993. Persons 
who wish to speak at the hearing should contact 
John P. Barkley at (919)733-4618. Persons who 
call in advance of the hearing will be given 
priority on the speaker's list. Oral presentation 
lengths may be limited depending on the number of 
people that wish to speak at the public hearing. 
Only persons who have made comments at a public 
hearing or who have submitted written cotnments 
will be allowed to speak at the Commission 
meeting. Comments made at the Commission 
meeting must either clarify previous comments or 
proposed changes from staff pursuant to comments 
made during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS, GROUPS, BUSINESSES. 
ASSOCIATIONS, IN^UTUTIONS OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS, WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED RULES. THE 
COMMISSION MAY MAKE CHANGES TO THE 
RULES AT THE COMMISSION MEETING IF THE 
CHANGES COMPLY WITH G.S. 150B-2I.2(f). 

CHAPTER 19 
HEALTH: EPIDEMIOLOGY 

SUBCHAPTER 19A - COMMUNICABLE 
DISEASE CONTROL 

SECTION .0400 - IMMUNIZATION 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1135 



PROPOSED RULES 



.0401 DOSAGE AND AGE REQUIREMENTS 
FOR IMMUNIZATION 

(a) Every individual in North Carolina required 
to be immunized pursuant to G.S. 130A-152 
through 130A-157 shall be immunized against the 
following diseases by receiving the specified 
minimum doses of vaccines by the specified ages: 

(1) diphtheria, tetanus, and whooping 
cough — five doses: three doses by age 
one year and two booster doses, one in 
the second year of life and the second 
on or after the fourth birthday and 
before enrolling in school (K-1) for the 
first time; 

(2) oral poliomyelitis vaccine— three doses 
of trivalent type by age two years and a 
booster dose of trivalent type on or 
after the fourth birthday and before 
enrolling in school (K-1) for the first 
time; two doses of enhanced-potency 
inactivated poliomyelitis vaccine may 
be substituted for two doses of oral 
poliomyelitis vaccine; 

(3) measles (rubeola) vaccine — ono doso 
two doses of live, attenuated vaccine^ 
one dose by age two years and a second 
dose before enrolling in school (K-1) 
for the first time ; 

(4) rubella vaccine — one dos e two doses of 
live, attenuated vaccine^ one dose by 
age two years and a second dose before 
enrolling in school (K-1) for the first 
time; 

(5) mumps vaccine — ono doo e two doses 
of live, attenuated vaccine^ one dose by 
age two years and a second dose before 
enrolling in school (K-1) for the first 
time : 

(6) Hemophilus influenzae, b, conjugate 
vaccine — three doses of HbOC or two 
doses of PRP-OMP by age one year 
and a booster dose of any type by the 
second birthday; and 

(7) hepatitis B vaccine - three doses by 
age one year. 

(b) Notwithstanding the requirements of Para- 
graph (a) of this Rule: 

(1) An individual who has attained his or 
her seventh birthday without having 
been immunized against whooping 
cough shall not be required to be immu- 
nized with a vaccine preparation con- 
taining whooping cough antigen. 

(2) An individual who has been document- 
ed by serologic testing to have a protec- 



tive antibody titer against rubella shall 
not be required to receive rubella vac- 
cine. 

(3) An individual who has been diagnosed 
prior to January 1^ 1994, by a physi- 
cian licensed to practice medicine as 
having measles (rubeola) disease shall 
not be required to receive measles 
vaccine. 

(4) An individual attending school who has 
attained his or her 18th birthday shall 
not be required to receive oral polio 
vaccine. 

(5) An individual bom prior to 1957 shall 
not be required to receive measles 
vaccine. An individual who has at- 
tained his or her fiftieth birthday shall 
not be required to receive rubella vac- 
cine. An individual who entered a 
college or university after his or her 
thirtieth birthday and before February 
1, 1989 shall not be required to meet 
the requirement for rubella vaccine. 

(6) Except as provided in Subparagraph 
(b)(8) of this Rule, the requirements for 
mumps vaccine, and for booster doses 
of diphtheria, tetanus, and whooping 
cough vaccine and oral poliomyelitis 
vaccine, shall not apply to individuals 
who enrolled for the first time m the 
first grade before July 1, 1987. 

(7) Individuals who receive the first booster 
dose of diphtheria, tetanus, and whoop- 
ing cough vaccine on or after the fourth 
birthday shall not be required to have a 
second booster dose. Individuals who 
receive the third dose of oral poliomy- 
elitis vaccine on or after the fourth 
birthday shall not be required to receive 
a fourth dose. 

(8) Individuals attending a college or uni- 
versity shall be required to have three 
doses of diphtheria/tetanus toxoid of 
which one must have been within the 
last ten years. 

(9) Individuals bom before October 1, 
+W4- 1988 shall not be required to be 
vaccinated against Hemophilus 
influenzae, b. Individuals who receive 
the first dose of Hemophilus influenzae, 
b, vaccine on or after 12 months of age 
and before 15 months of age shall be 
required to have only two doses of 
HbOC or PRP-OMP Individuals who 
receive the first dose of Hemophilus 



1136 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



(10) 



fllj 



influenzae, b, vaccine on or after 15 
months of age shall be required to have 
only one dose of any of the hemophilus 
influenzae conjugate vaccines, including 
PRP-D. 

Individuals bom on or after July L, 
1994 shall not be required to be vacci- 
nated against hepatitis R 
Except as provided in Subparagraph (b) 
(12) of this Rule, the requirement for a 
second dose of measles, mumps and 
rubella vaccine shall not apply to indi- 
viduals who enroll in school (K-1) for 
the first time on or before July 1, 1994. 



(12) 



Individuals who enroll in a college or 
university for the first time after July \^ 
1994 shall be required to have a second 
dose of measles, mumps and rubella 
vaccine. 



Statutory Authority G.S. 130A-1 52(c); 
130A-155. 1. 

.0406 ACCESS TO IMMUNIZATION 
INFORMATION 

(a) Immunization information may be released in 
whole or in part to anyone not specified m G.S. 
130A-153 and this Rule with the written consent of 
the person identified or their parent, guardian^ or 
person standing in loco parentis. 

(b) Immunization information specified in 
Paragraph (c) of this Rule may also be obtained 
without consent from a physician or local health 
department upon request by: 

(1) schools K-1 2, whether public, private 
or religious; 

(2) licensed and registered daycare facilities 
as defined in G.S. 110-86(3) and G.S. 
110 102 110-101 ; 

(3) Head Start; and 

(4) colleges and universities, whether 
public, private or religious. 

(c) Upon request, persons specified in Paragraph 
(b) of this Rule may obtain the following 
information without consent about each individual 
for whom the person is required to receive a 
certificate of immunization is r e quir e d by G.S. 
130A-155 and 155.1; 

(1) name and address; 

name of the parent, guardian, or person 

standing in loco parentis; 

date of birth; 

gender; 

race; 

vaccine type, date and dose 



(2) 

(3) 
(4) 
151 
(6) 



administered; 

(7) the name and address of the physician 
or health department that administered 
each dose; and 

(8) the existence of a medical or religious 
exemption determined by the Immuni- 
zation Branch to meet the requirements 
of G.S. BOA- 156 and 15A NCAC 19A 
.0404 or OS, 130A-157. If such a 
determination has not been made by the 
Immunization Branch, the person shall 
have access to the certification of medi- 
cal and religious exemptions pursuant 
required te by G.S. 130A-156 aed or 
G.S. 130A- 157 and 15A NCAC 19A 
.0404. 

Statutory Authority G.S. 130A-153. 

SECTION .0500 - PURCHASE AND 
DISTRIBUTION OF VACCINE 

.0502 VACCINE FOR PROVIDERS OTHER 
THAN LOCAL HEALTH 
DEPARTMENTS 

(a) The Department of Environment, Health, 
and Natural Resources provides vaccines required 
by law free of charge to the following providers 
for administration to individuals who need vaccines 
to meet the requirement of G.S. 130A-152, 
130-155.1 and 15A NCAC 19A .0401: 

(1) Community, migrant, and rural health 
centers; 

(2) Colleges and universities for students; 
and 

(3) Physicians and other health care 
providers^ te — administer — te — pati e nts 
whose gross family income is less than 
or e qual to 1 8 5 p e rcent of the f e deral 
poverty l e vel. 

(b) Upon request of the Department, required 
vaccines shall may be distributed by local health 
departments operating as agents of the State to 
providers listed in Subparagraphs (a) (1). (2) and 
(3) of this Rule. 

(c) Providers authorized in Paragraph (a) of this 
Rule shall be eligible to receive free vaccines from 
the Department only if they sign an agreement 
with the Department. This agreement will be 
prepared by the Immunization Branch and will 
require the provider to administ e r such vaccin e s 
only to eligible pati e nts; to^ 

(1) Charge no more than sixteen dollars 
and forty eight cents ($16.48) as a eftly 
a reasonable administration fee for 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1137 



PROPOSED RULES 



administration of all vaccines given at a 

single visit; 
(T) provide all vaccines needed during a 

visit unless a specific contraindication 

exists to one or more of the vaccines; 
(3) Charge no additional office fee for an 

immunization-only visit; 
£4} Agree to waive the administration fee if 

a patient is unable to pay; 

(5) Impose no condition as a prerequisite to 
receiving vaccine; 

(6) to s ubmit monthly vaccin e reports on a 
fomn — prepar e d — by — tbe — Immunization 
Branch Report in writing or electroni- 
cally the name and social security num- 
ber of the person to whom vaccine was 
administered, the date of administra- 
tion, the type and dose of vaccine(s) 
administered and the provider number 
of the physician or clinic administering 
the vaccine to the Immunization 
Branch, at least monthly by the fifth 
day of each month; 

(7) te Report adverse vaccine reactions 
through the Vaccine Adverse Event 
Reporting System (VAERS); 

(8) te Obtain a signed Par e nt Patient Notifi 
cation — (PPN) Important Information 
Statement (IIS). Vaccine Information 
Pamphlet (VIP), or a separate signature 
card or log sheet that contains a declar- 
ative statement specified by the Branch 
for each dose of vaccine administered; 
and to retain the signed portion for a 
period of 10 years following the end of 
the calendar year in which the form 
was signed, or for 10 years following 
the recipient's age of majority, which- 
ever is longer; aftd upon request, fur- 
nish copies of the signed portion to the 
local health department or the Depart- 
ment; te Keep a record of the vaccine 
manufacturer, lot number, and date of 
administration for each dose of vaccine 
administered; 

(9) te Allow periodic inspection of their 
vaccine supplies and records by the 
Immunization Branch; and 

(10) te Comply with the rules of this Sec- 
tion. 

(d) A provider who foils to submit timely and 
accurate reports, as required in Paragraph (c) of 
this Rule, twice in any 12 month period shall have 
their eligibility to receive state vaccine suspended 
for a period of one year. A provider who fails to 



comply with any of the other requirements of this 
Rule may have their eligibility suspended by the 
Department for a period determined by the Depan- 
ment and may be subject to an action brought 
pursuant to G.S. 130A-27. All suspensions of 
eligibility shall be in accordance with G.S. 
130A-23. 

Authority S.L. 1986, c. 1008. s. 2: S.L. 1987, c. 
215, s. 7; G.S. 130A-152: 130A-155.1. 

ISotice is hereby given in accordance mth G.S. 
150B-21.2that the EHNR - Commission for Health 
Ser\'ices intends to amend rules cited as 15A 
NCAC 19B .0101 and .0503. 

1 he proposed effective date of this action is 
January 4, 1994. 

1 he public hearing will be conducted at 10:00 
a.m. on October 15, 1993 at the Archdale Build- 
ing, Groundfloor Hearing Room, 512 N. Salisbury 
Street. Raleigh, NC. 

Ixeason for Proposed Action: This allows the 
transition for checking calibration of instruments 
from 0. 10 to 0. 08 pursuant to Ratified House Bill 
385 which changes the 0. 10 DWl Law to 0.08. 

L^omment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P. O. Box 629, 
Raleigh, NC 27602-0629. All written comments 
must be received by October 20, 1993. Persons 
who wish to speak at the hearing should contact 
John P. Barkley at (919)733-4618. Persons who 
call in advance of the hearing will be given 
priority on the speaker's list. Oral presentation 
lengths may be limited depending on the number of 
people that wish to speak at the public hearing. 
Only persons who have niade comments at a public 
hearing or who have submitted written comments 
will be allowed to speak at the Commission 
meeting. Conunents made at the Commission 
meeting must either clarify previous comments or 
proposed changes from staff pursuant to conunents 
made during the public hearing process. 



1138 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS. GROUPS, BUSINESSES, 
ASSOCIATIONS, INSTITUTIONS OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS. WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED RULES. THE 
COMMISSION MAY MAKE CHANGES TO THE 
RULES AT THE COMMISSION MEETING IF THE 
CHANGES COMPLY WITH G.S 1503-21. 2(f). 

CHAPTER 19 - HEALTH: EPIDEMIOLOGY 

SUBCHAPTER 19B - INJURY CONTROL 

SECTION .0100 - GENERAL POLICIES 

.0101 DEFINITIONS 

The definitions in G.S. 18B-101, G.S. 20-4.01, 
G.S. 130A-3 and the following shall apply 
throughout this Subchapter: 

(1) "Alcoholic Breath Simulator" shall mean 
a specially designed constant temperature 
water-alcohol solution bath instrument 
devised for the purpose of providing a 
standard alcohol-air mixture; 

(2) "Ampul" means a small bulbous glass 
vessel hermetically sealed containing an 
alcohol-sensitive reagent consisting of at 
least 3 ml. of a solution containing, 
within plus or minus 10 percent, 0.025 
percent weight per volume (w/v) 
potassium dichromate plus 0.025 percent 
w/v silver nitrate in 50 percent volume 
per volume (v/v) sulfuric acid and 
distilled water; 

(3) "Breath-testing Instrument" shall mean an 
instrument for making a chemical 
analysis of breath and giving the resultant 
alcohol concentration in grams of alcohol 
per 210 liters of breath or an instrument 
that reports an alcohol concentration as 
percent blood alcohol, which shall mean 
grams of alcohol per 210 liters of breath; 

(4) "Controlled Drinking Program" shall 
mean a bona fide scientific, experimental, 
educational, or demonstration program in 
which tests of a person's breath or blood 
are made for the purpose of determining 
his alcohol concentration when such 
person has consumed controlled amounts 
of alcohol; 



(5) "Director" shall mean the Director of the 
Division of Epidemiology of the 
Department; 

(6) "Handling Alcoholic Beverages" shall 
mean the acquisition, transportation, 
keeping in possession or custody, 
storage, administration, and disposition 
of alcoholic beverages done in connection 
with a controUed-drinking program; 

(7) "Observation Period" means a period 
during which a chemical analyst observes 
the person to be tested to determine that 
he has not ingested alcohol or other 
fluids, regurgitated, vomited, eaten, or 
smoked in the 15 minutes immediately 
prior to the collection of a breath 
specimen; the chemical analyst may 
observe while conducting the operational 
procedures in using a breath-testing 
instrument, and if a chemical analyst 
other than the one conducting the analysis 
is the observer, both chemical analysts 
must sign the operational checklist; 

(8) "Permittee" shall mean a chemical 
analyst currently possessing a valid 
permit from the Department to perform 
chemical analyses, of the type set forth 
within the permit; 

(9) "Simulator Solution" shall mean a 
water-alcohol solution made by preparing 
a stock solution of 60.5 grams of alcohol 
per liter of solution (77.0 ml. of absolute 
alcohol diluted to one liter with distilled 
water, or equivalent ratio) and then 
preparing the solution for simulator use 
as a control sample by using either 10 
ml. or 8 ml. of stock solution and further 
diluting the solution to 500 ml. with 
distilled water, which then corresponds to 
the equivalent alcohol concentration of 
OT40t 0. 10 or 0.08 respectively. 

(10) "Verification of Instrumental Calibration" 
shall mean verification of instrumental 
accuracy by employment of a control 
sample from an alcoholic breath 
simulator using solution as specified in 
Ptimgraph Item (9) of this Rule and 
obtaining a result of 0. 10 or 0.09 alcohol 

concentration:; with an allowable 

in s trumental d e viation not to exc ee d 10 
perc e nt und e r 0. 10 alcohol concentration. 
Deviations — en — the — high — side — are — net 
permitt e d, when using 10 ml. of stock 
solution or a result of 0.08 or 0.07 when 
using 8 ml. of stock solution. When the 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1139 



PROPOSED RULES 



procedures set forth for instruments in 
Section .0300 of th e s e Rul e o this Subchap- 
ter are followed and the result specified 
herein is obtained, the instrument shall be 
deemed properly calibrated. 

Statutory Authority G. S. 20-139. 1 (b); 20-139. 1 (g). 

SECTION .0500 - ALCOHOL SCREEIVING 
TEST DEVICES 

.0503 APPROVED ALCOHOL SCREENING 
TEST DEVICES: CALIBRATION 

(a) The following breath alcohol screening test 
devices are approved as to type and make: 

(1) ALCO-SENSOR (with two-digit dis- 
play), made by Intoximeters, Inc. 

(2) ALCO-SENSOR III (with three-digit 
display), made by Intoximeters, Inc. 

(3) BREATH-ALCOHOL TESTER MOD- 
EL BT-3, made by RepCo., Ltd. 

(4) ALCOTEC BREATH-TESTER, made 
by RepCo., Ltd. 

(5) ALCO-SENSOR IV, manufactured by 
Intoximeters, Inc. 

(6) PBA 3000, manufactured by Life Loc, 
Inc. 

(7) SD-2, manufactured by CMI, Inc. 

(b) Calibration of alcohol screening test devices 
shall be verified at least once during each 30 day 
period of use by employment of a control sample 
from an alcoholic breath simulator or an ethanol 
gas standard. TTie device shall be deemed proper- 
ly calibrated when th« a result of 0.09 or 0. 10 or 
0.09 is obtained using 10 ml. of stock solution or 
when a result of 0.08 or 0.07 is obtained using 8 
ml. of stock solution. 

(1) Alcoholic breath simulators used exclu- 
sively for calibration of alcohol screen- 
ing test devices shall have the solution 
changed every 30 days or after 25 
calibration tests, whichever occurs first. 

(2) Requirements of Paragraph (b) and 
Subparagraph (b)(1) of this Rule shall 
be recorded on an alcoholic breath 
simulator log designed by the Injury 
Control Section and maintained by the 
user agency. 

Statutory' Aiithorm- G.S. 20-16.3. 






Nc 



otice is herein' ?iven in accordance with G.S. 



150B-21.2 that EHNR - Commission for Health 
Services intends to amend rule cited as 15A NCAC 
19C .0102 and adopt rules cited as 15A NCAC 
19C .0701 - .0703. 

1 he proposed effective date of this action is 
January 4, 1994. 

1 he public hearing mil be conducted at 10:00 
a.m. on October 15. 1993 at the Groundfloor 
Hearing Room, Archdale Building, 512 N. Salis- 
bury Street. Raleigh, N.C. 

iveason for Proposed Action: On July 23, 1993, 
the General Assembly ratified Senate Bill 533 
mandating statewide reporting of occupational 
diseases, illnesses, and injuries. This action is 
proposed to Implement this legislation. 

(comment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice. P.O. Box 629, 
Raleigh, NC 27602-0629. All written comments 
must be received by October 20, 1993. Persons 
who wish to speak at the hearing should contact 
John P Barkley: at (919)733-4618. Persons who 
call in advance of the hearing will be given 
priority on the speaker's list. Oral presentation 
lengths may be limited depending on the number of 
people that wish to speak at the public hearing. 
Only persons who have made comments at a public 
hearing or who have submitted written conmients 
will be allowed to speak at the Commission 
meeting. Comments made at the Commission 
meeting must either clarify prexdous comments or 
proposed changes _from staff pursuant to comments 
made during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS, GROUPS, BUSINESSES, 
ASSOClAnONS, INSnTUTlONS OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS, WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED RULES. THE 
COMMISSION MAY MAKE CHANGES TO THE 
RULES AT THE COMMISSION MEETING IF THE 



1140 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



CHANGES COMPLY WITH G.S. 150B-2L2(f). 

CHAPTER 19 
HEALTH: EPIDEMIOLOGY 

SUBCHAPTER 19C - OCCUPATIONAL 
HEALTH 

SECTION .0100 - GENERAL 

.0102 ACTIVITIES 

(a) The Occupational Health Section shall 
conduct programs to help obtain a safe and healthy 
workplace. The activities shall include at least the 
following: 

(1) support the North Carolina Industrial 
Commission in meeting the legislative 
mandate assigned to evaluate and con- 
trol incidences of asbestosis and silico- 
sis in dusty trades; 

(2) supply program consultation services to 
North Carolina employers to evaluate 
hazardous conditions and recommend 
solutions and improvements; 

(3) provide occupational health nursing 
consultation to industries, academia, 
health care and related agencies and 
affiliated professions; 

(4) evaluate health conditions in places of 
employment; 

(5) implement the Asbestos Hazard Man- 
agement Program in Section .0600 of 
these RulesT^ 

(6) implement the Occupational Health 
Surveillance Section .0700 of these 
Rules. 



(b) The Occupational Health Section shall also 
offer technical assistance to other state and federal 
agencies. 

Statutory Authority G.S. I30A-5(3). 

SECTION .0700 - OCCUPATIONAL 
HEALTH SURVEILLANCE 

.0701 DEFINITIONS 

"Elevated blood lead toxicity" means a blood 
lead of 25 ug/dL or greater. 

Statutory Authority G.S. 130A-455. 



health and are hereby made reportable within the 
time period specified after the disease, illness, and 
injury is diagnosed: 

(1) asbestosis ; five working days; 

(2) silicosis ; five working days; 

(3) elevated adult blood lead toxicity ; five 
working days; 

(4) injuries caused by tractors, farm equip- 
ment, or farm machinery that occur while 
working on a farm ^ five working days. 

Statutory Authority G.S 130A-455: 130A-456; 
130A-457; 130A-458. 

.0703 METHOD OF REPORTING 

(a) When a physician makes a report of a dis- 
ease, illness, or injury pursuant to G.S. 130-456 or 
a medical facility makes such a report pursuant to 
G.S. 130-457, the report shall be made to the 
Occupational Health Section as follows: 

(1) The report shall be made on the surveil- 
lance forms provided by the Occupa- 
tional Health Section and shall include 
the foUowmg information: 

(A) The name, address, telephone num- 
ber, date of birth, social security 
number, race, gender, and job title of 
the person; 

(B) The name, address, telephone num- 
ber, and type of business of the 
person's employer: 

(C) The name of the disease, illness, or 
injury being reported and date of 
onset; and 

(D) The name, address, and telephone 

laboratory. 



£21 



The name, 

number of the physician 
or medical facility- 
Surveillance forms are available 



from 



the SENSOR Program. 
Health Section. N.C. 



Occupational 
Division of 



Epidemiology. P.O. Box 
Raleigh. N.C. 27611-7687. 



27687. 



(b) All laboratories that perform blood lead tests 
shall report to the Occupational Health Section 
elevated blood lead levels for adults aged 18 years 
of age and above. The reports of the blood lead 
results shall include the specimen collection date. 
the person's name, age, gender, race, the 
submitting physician's name. address. and 
telephone number. 



.0702 REPORTABLE DISEASES, 

ILLNESSES, AND INJURIES 

The following named diseases, illnesses, and 
injuries are declared to be dangerous to the public 



Statutory Authority G.S 130A-455; ]30A-458. 






8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1141 



PROPOSED RULES 



lylotice is hereby given in accordance with G.S. 
150B-21.2that the EHNR - Commission for Health 
Services intends to amend rules cited as 15A 
NCAC21A .0816- .0818. 

1 he proposed effective date of this action is 
January 4. 1994. 

1 he public hearing will be conducted at 10:00 
a.m, on October 15, 1993 at the Archdale Build- 
ing, Groundfloor Hearing Room, 512 N. Salisbury 
Street, Raleigh, NC. 

tveason for Proposed Action: This amendment 
reflects legislative changes and intent and increas- 
es the maximum first year funding for projects 
receiving grants from the Adolescent Pregnancy 
Prewntion Program. These changes do not 
require the appropriation of additional state and 
local funds. 

X^omment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P. O. Box 629, 
Raleigh, NC 27602-0629. All written comments 
must be received by October 20, 1993. Persons 
who wish to speak at the hearing should contact 
John P Barkley at (919)733-4618. Persons who 
call in advance of the hearing will be given 
priority on the speaker's list. Oral presentation 
lengths may be limited depending on the number of 
people that wish to speak at the public hearing. 
Only persons who have made comments at a public 
hearing or who have submitted written comments 
will be allowed to speak at the Commission 
meeting. Comments made at the Cotmrdssion 
meeting must either clarify prex'ious comments or 
proposed changes from staff pursuant to comments 
made during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS, GROUPS. BUSINESSES, 
ASSOCIATIONS. INSUTUTIONS OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS. WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED RULES. THE 



COMMISSION MAY MAKE CHANGES TO THE 
RULES AT THE COMMISSION MEETING IF THE 
CHANGES COMPLY WITH G.S 150B-21 .2(f>. 

CHAPTER 21 - HEALTH: PERSONAL 
HEALTH 

SUBCHAPTER 21A - WOMEN'S 
PREVENTIVE HEALTH 

SECTION .0800 - ADOLESCENT 
PREGNANCY PREVENTION PROJECTS 

.0816 DEFINITIONS 

The following definitions shall apply throughout 
this Subchapter: 

(1) "APPP" means the Adolescent Pregnancy 
Prevention Program administered by the 
Division of Maternal and Child Health. 

(2) "Division of MCH" means the Division 
of Maternal and Child Health. Depart- 
ment of Environment, Healthy and Natu- 
ral Resources. 

(3) "Contractor" means a county or district 
health department or other public or 
private agency receiving APPP Project 
funds. 

(4) "Adolescent" means any individual 19 
years of age and under. 

(5) "Major Equipment" means any fixed 
asset that has a unit cost of two thousand 
dollars ($2,000) or more. 

(6) "Minor Remodeling" means any building 
or facility reconstruction project having a 
total cost of two thousand dollars 
($2,000) or less. 

(7) "Primary pregnancy prevention" means 
prevention of first pregnancy. 

Statutory Authority G.S 130A-124: S.L. 1989. c. 
752. s. 136. 

.0817 GRANT PROPOSALS 

(a) Grants shall be awarded through a request 
for proposal (RFP) process that includes 
notification of potential applicant agencies of the 
eligibility criteria and requirements for funding. 

(b) Grant proposals shall include information 
specified in Chapter 752, Section 136. 1989 
Session Laws, and other information required by 
the Division of MCH in the RFR 

fe^ — Grant proposals shall includ e th e following: 

fH e vid e nc e of public notice and a public 

h e aring on th e proposal, held by th e 
appropriat e board or council as follows: 



1142 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



{A) — tho board of county oommission e ro or 

ito dooign ee , or 
{B) — th e city oounoil or its d e sign ee , if th e 
arcxx in whioh th e projoot will op e rat e 
is oololy within th e boundari e s of a 
municipality; and 

(3) a statement of oommunit^' support for 

tho proposal, as submitt e d, from the 
board or oounoil that oonduot e d th e 
publio hearing on th e proposal. 

(c) The Division of MCH, in reviewing propos- 
als of equal merit, shall give priority to those 
proposals focusing on male responsibility. 

(d) The Division of MCH must allocate at least 
75 percent of APPP funds for projects whose main 
focus is primary pregnancy prevention. 

Statutory Authority G.S. 130A-124; S.L. 1989. c. 
752, s. 136. 



these matters are invited to attend the public 
hearing. Written convnents may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P.O. Box 629, 
Raleigh, NC 27602-0629. All written comments 
must be received by October 20, 1993. Persons 
who wish to speak at the hearing should contact 
John P. Barkley at (919)733-4618. Persons who 
call in advance of the hearing will be given 
priority on the speaker's list. Oral presentation 
lengths may be limited depending on the number of 
people that wish to speak at the public hearing. 
Only persons who have made comments at a public 
hearing or who have submitted written comments 
will be allowed to speak at the Commission 
meeting. Comments made at the Commission 
meeting must either clarify previous convnents or 
proposed changes from staff pursuant to comments 
made during the public hearing process. 



.0818 MAXIMUM FUNDING LEVEL 

The maximum level of funding for any one 
project in the first year shall be sixty seventy-five 
thousand dollars ($60,000) ($75.000) . 

Statutory Authority G.S. 130A-124; S.L. 1989, c. 
752, s. 136. 

ISotice is hereby given in accordance with G.S. 
150B-21.2that the EHNR - Commission for Health 
Services intends to amend rule cited as 15A NCAC 
21 B .0304. 

1 he proposed effective date of this action is 
January 4, 1994. 

1 he public hearing will be conducted at 10:00 
a.m. on October 15, 1993 at the Archdale Build- 
ing, Groundfloor Hearing Room, 512 N. Salisbury 
Street, Raleigh, NC. 

ixeason for Proposed Action: This amendment 
reflects legislative changes as per the 1993 Session 
of the General Assembly, Chapter 321 , Senate Bill 
27, Section 283, Page 211. These changes do not 
require the appropriation of any additional state 
and local funds. 

\^omment Procedures: All persons interested in 



IT IS VERY IMPORTANT THAT ALL 
INTERESTED AND POTENTIALLY AFFECTED 
PERSONS, GROUPS, BUSINESSES, 
ASSOCIAUONS, INSnTUnONS OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS. WHETHER THEY 
SUPPORT OR OPPOSE ANY OR ALL 
PROVISIONS OF THE PROPOSED RULES. THE 
COMMISSION MAY MAKE CHANGES TO THE 
RULES AT THE COMMISSION MEETING IF THE 
CHANGES COMPLY WITH G.S 150B-21.2(f). 

CHAPTER 21 - HEALTH: PERSONAL 
HEALTH 

SUBCHAPTER 21B - MATERNAL HEALTH 

SECTION .0300 - RURAL OBSTETRICAL 
CARE INCENTIVE FUNDS 

.0304 DISBURSEMENT OF FUNDS 

(a) Subject to the availability of funds, the 
Maternal Health Branch shall disburse rural 
obstetrical care incentive funds to local health 
departments that have submitted an approved 
application as follows: 

(1) first priority shall be given to those 
counties that meet the criteria in Rule 
.0302(b)(1), second priority shall be 
given to those counties that meet the 
criteria in Rule .0302(b)(2), third 
priority shall be given to those counties 
that meet the criteria in Rule 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1143 



PROPOSED RULES 



.0302(b)(3), and fourth priority shall be 
given to those counties that meet one or 
more of the criteria in Rule 
.0302(b)(4); 

(2) the Maternal Health Branch shall rank 
and disburse funds to underserved 
counties within each priority group 
according to the anticipated 
improvement in obstetrical coverage 
that will result from funding; and 

(3) Counties funded shall receive ongoing 
funding based upon a renewal 
application that has been reviewed and 
approved by the Maternal Health 
Branch. 

(b) For each eligible physician with whom the 
local health department contracts, the health 
department will be paid either the difference 
between the physician's premiums with obstetrical 
care coverage and without obstetrical care 
coverage, or si* seven thousand five hundred 
dollars ($6,500) ($7.500) , whichever is less. 
Payment shall be based upon a maximum of one 
million/one million dollars 
($1,000,000/$ 1,000,000) coverage. The local 
health department will then pay this amount to the 
physician to cover a portion of the physician's 
annual malpractice insurance premiums. The total 
payments to one physician cannot exceed the 
amount stated in this Paragraph. 

(c) For each eligible nurse-midwife with whom 
the local health department contracts, the health 
department will be paid the total amount of the 
nurse-midwife's premium or thr ee four thousand 
dollars ($3,000) ($4,000) er^ whichever is less. 
The local health department will then pay this 
amount to the nurse-midwife to cover a portion of 
the nurse-midwife's annual malpractice insurance 
premiums. The total payments to one nurse- 
midwife cannot exceed the amount stated in this 
Paragraph . 

(d) No more than nin e t e en thirty thousand ftve 
hundr e d dollars ($19,500) ($30,000) may be 
disbursed to any underserved county. 

(e) No funds my be disbursed to a health 
department in the absence of a contract with an 
eligible physician of nurse-midwife. 

Statutory Authorin- S.L. 1989, c. 1066. s. 49. 

IS otice is hereby given in accordance with G.S. 
150B-21.2 that EHNR - Commission for Health 



Services intends to amend rule cited as 15A NCAC 
24A .0302. 

1 he proposed effective date of this action is 
January 4, 1994. 

1 he public hearing will be conducted at 10:00 
a.m. on October 15, 1993 at the Groundftoor 
Hearing Room, Archdale Building, 512 N. Salis- 
bury Street. Raleigh. N.C. 

MXeason for Proposed Action: This amendment 
extends time frames for both Authorisation Re- 
quests and claims to one year from date of service 
(currently 90 days for Authori:xition Requests and 
180 days for claims). This insurance and other 
third party payers and still have time to bill 
DEHNR programs if that is needed. This will also 
reduce the number of appeals filed because of 
denials due to late Authori:xition Requests or late 
claims. 

i^omment Procedures: All persons interested in 
these matters are invited to attend the public 
hearing. Written comments may be presented at 
the public hearing or submitted to John P. 
Barkley, Department of Justice, P.O. Box 629, 
Raleigh, NC 27602-0629. All written comments 
must be received by October 20, 1993. Persons 
who wish to speak at the hearing should contact 
John P Barkley at (919)733-4618. Persons who 
call in advance of the hearing will be given 
priority on the speaker's list. Oral presentation 
lengths may be limited depending on the number of 
people that wish to speak at the public hearing. 
Only persons who have made comments at a public 
hearing or who have submitted written com/nents 
will be allowed to speak at the Commission 
meeting. Comments made at the Commission 
meeting must either clarify pre\ious comments or 
proposed changes from staff pursuant to comments 
made during the public hearing process. 

IT IS VERY IMPORTANT THAT ALL 
INTERESTED .AND POTENTIALLY AFFECTED 
PERSONS, GROUPS. BUSINESSES. 
ASSOCIATIONS, INSHTUTIONS OR AGENCIES 
MAKE THEIR VIEWS AND OPINIONS KNOWN 
TO THE COMMISSION FOR HEALTH SERVICES 
THROUGH THE PUBLIC HEARING AND 
COMMENT PROCESS, WHETHER THEY SUP- 
PORT OR OPPOSE ANY OR ALL PROVISIONS 



1144 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



OF THE PROPOSED RULES. THE COMMIS- 
SION MAY MAKE CHANGES TO THE RULES AT 
THE COMMISSION MEETING IF THE CHANGES 
COMPLY WITH G.S I50B-2I.2(f). 

CHAPTER 24 - GEIVERAL PROCEDURES 
FOR PUBLIC HEALTH PROGRAMS 

SUBCHAPTER 24A - PAYMENT 
PROGRAMS 

SECTION .0300 - ELIGIBILITY 
PROCEDURES 

.0302 AUTHORIZATIONS AND CLAIMS 
PROCESSING TIME FRAMES 

The following time frames shall apply to all 
payment programs: 

(1) An Authorization Request must be re- 
ceived by the Department within 90 days 
one year after the date of service or it 
will be denied. 

(2) The Department shall respond to an 
Authorization Request within 45 days 
after receipt. 

(3) If additional information is requested, 
this information must be received within 
90 days one year after the date of service 
or within 30 days after the date of the 
Department's request, whichever is later, 
or the Authorization Request will be 
denied. 

(4) The Department shall approve or deny an 
Authorization Request within 45 days 
after receipt of all necessary information. 

(5) A claim for payment must be received by 
the Department within 1 80 days one year 
after the date of service or within 45 days 
after the date of authorization approval, 
whichever is later, or the claim will be 
denied. Corrections to claims and re- 
quests for payment adjustment must be 
received by the Department within one 
year after the date of service or within 45 
days after the date the claim is paid or 
returned for additional information, 
whichever is later, or the claim will be 
denied. 

(6) A claim shall show paym e nts by other 
third party payors or it shall show that all 
oth e r payors hav e d e ni e d paym e nt or that 
there are no oth e r payors. — Onc e another 
payor ha s boon bill e d, if no r e sponse has 
boon r e ceiv e d within 80 days after th e 
dat e of servic e , th e provider may bill the 



(7) 
(8) 



D e partm e nt, but th e claim shall indicate 
that th e oth e r payor has b ee n bill e d and 
no r e spons e has b e en rec e iv e d. — If pay 
m e nt is r e ceiv e d later from th e other 
payor, — the — provider — shall — r e fund — tbe 
D e partm e nt. If there are other third 
party payors, a claim must show pay- 
ments by those payors or it must include 
copies of the denials of payment from 
those payors. Providers must bill other 
payors and wait at least six months after 
the date of service to receive payment or 
denial of payment before billing the 
Department. If no response has been 
received within six months after the date 
of service, the provider may bill the 
Department, but the claim must state the 
date that the other payors were billed. 
Providers of pharmacy outpatient services 
are required to bill Medicaid. However, 
they are not required to bill other third 
party payors and wait 8 days six months 
before billing the Department but are 
required to refund the Department if 
other third party payments are received. 
The Department shall pay or deny a 
claim within 45 days after receipt of a 
completed claim. 

Authorization Requests and claims for 
payment shall be submitted on forms 
approved by the Department. 



Statutory Authority G.S. I30A-5(3); I30A-I24; 
I30A-I27; I30A-I29; I30A-205. 

TITLE 19A - DEPARTMENT OF 
TRANSPORTATION 

iS otice is hereby given in accordance with G.S. 
150B-21.2 that the Division of Motor Vehicles 
intends to amend rule cited as 19A NCAC 3D 
.0224. 

1 he proposed effective date of this action is 
December I, 1993. 

Instructions on How to Demand a Public Hearing 
(must be requested in writing within 15 days of 
notice): The agency will schedule a public hearing 
on the proposed rule if it receives a written request 
for a hearing within 15 days from the date the 
proposed text is published. The request for hear- 
ing must be mailed to: Jerry Arrowood, Enforce- 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1145 



PROPOSED RULES 



merit Section, Division of Motor Vehicles, 1100 
New Bern Avenue, Raleigh, NC 27697. 

Ixeason for Proposed Action: To provide for 
rewcation of a motor vehicle dealer 's license for 
failure to pay the civil penult}- assessed by the 
Division of Motor Vehicles pursuant to G. S. 20- 
79(e)(2). 

X^omment Procedures: ViHtten comments on the 
proposed rule may be submitted by mailing the 
comments to the following address within 30 days 
after the proposed text is published or until a 
requested public hearing is held, whichever is 
longer: Jerry Arrowood. Enforcement Section, 
Division of Motor Vehicles, 1100 New Bern Ave., 
Raleigh, NC 27697. 

CHAPTER 3 - DIVISION OF MOTOR 
VEHICLES 

SUBCHAPTER 3D - ENFORCEMENT 
SECTION 

SECTION .0200 - MOTOR VEHICLE 

DEALER, SALES. DISTRIBLTOR AND 

FACTORY REPRESENTATIVE LICENSE 

.0224 ILLEGAL USE OF DEALER 
PLATES 

(a) It is illegal to use dealer plates on vehicles 
operated for any other business that the dealer is 
engaged in. The sale of vehicles not required to 
be registered, excluding the sale of farm tractors 
which are part of the inventory of the dealer , is 
considered another business and delivery of such 
vehicles by motor transport is not permitted with 
dealer plates. 

(b) Parts trucks used in delivering parts to other 
sales outlets may use dealer plates only if the sale 
of parts is incident to the dealer business. A parts 
business that is separate and apart from the dealer- 
ship cannot use dealer plates. 

(c) It is illegal to use dealer plates on vehicles 
that are not owned by the dealer. 

(d) It is illegal for persons other than dealers, 
corporate officers^ — full time — afl^ — designated 
part time or employees of a dealer v.'ho regularly 

" work for the dealer at least 15 hours a week , to 
operate a dealership vehicle unless they are in 
possession of a 96-hour permit. The said permit 
must include license plate number, permitee's 
name, address, driver's license number, date and 



hour of issue and must be signed by dealer or sales 
manager and person receiving vehicle. A 
duplicate copy of the permit must be retained by 
the dealer. The permit is void Void if erasures are 
made. 

(e) It is illegal to use dealer plates on wreckers 
used for general wrecker service or on wreckers 
which move vehicles on a rotation basis at the 
request of state or local law enforcement 
authorities. It is permissible to use a dealer plate 
on wreckers which tow vehicles for the dealer's 
customers only. 

(f) Tlie civil penalty imposed upon a dealer 
pursuant to G.S. 20-79(e)(2) is due in ftiU upon 
assessment by the Division. The license of a 
dealer who fails to gay the civil penalty within 30 
days after notice of the assessment is delivered to 
the dealer or an employee of the dealer shall be 
revoked by the Division until the penalty is paid in 
full. 

Statutory Authority G.S 20-39; 20-79; 20-302. 

TITLE 20 - STATE TREASURER 

iS Otice is hereby given in accordance with G.S. 
150B-21.2 that the Board of Trustees of Firemen's 
and Rescue Squad "Workers ' Pension Fund intends 
to amend rules cited as 20 NCAC 2N .0209 and 
.0218. 

1 he proposed effective date of this action is 
December 1, 1993. 

1 he public hearing will be conducted at 10:00 
a.m. on October 4, 1993 at the Department of 
State Treasurer, Room 100, Albemarle Building, 
325 N. Salisbury Street. Raleigh, NC 27603. 

ixeason for Proposed Action: 
20 NCAC 2N . 0209 - To implement procedures for 
purchase of prior service credit with the Firemen 's 
and Rescue Squad Workers ' Pension Fund. 
20 NCAC 2N .0218 - To clarify^ payment of bene- 
fits for volunteer firemen and rescue squad workers 
for the Firemen's and Rescue Squad Workers' 
Pension Fund. 

(comment Procedures: Interested parties may 
comment either written or orally at the hearing. 
V^Yitten comments may be filed from September 15, 
1993 through October 15, 1993. Such written 



1146 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



comments must be sent to Stephen F. Albright, 
APA Coordinator, Dept. of State Treasurer, 325 
N. Salisbury Street, Raleigh, NC 27603. 

CHAPTER 2 - RETIREMENT SYSTEMS 

SUBCHAPTER 2N - NORTH CAROLINA 
FIREMEN'S PENSION FUND 

SECTION .0200 - GENERAL PROVISIONS 

.0209 PRIOR SERVICE CREDIT 

At the tim e an eligibl e fireman or an eligibl e 
rescue squad worker appli e s for m e mbership, h e 
or sh e may purchas e orodit for prior s e rvice as 
either an eligibl e fireman or an eligibl e rescu e 
squad work e r, provid e d that h e or s h e has not 
previously b e en a m e mber. — Prior s e rvic e cr e dit 
may b e purchased in no less than monthly incr e 
monto and up to a maximum of 12 months. — The 
coot of each month of prior servic e orodit shall b e 
the sam e as th e monthly paym e nt required by G.S. 
1 1 8 4 or 118 11 at the tim e of the application. 

Eligible prior service not purchased under the 
provisions of G.S. 58-86-45(b) may be purchase 
under the provisions of G.S. 58-86-45(al) by 
payment of a lump sum amount equal to the full 
liability of the service credits calculated on the 
basis of the assumptions used for purposes of the 
actuarial valuation of the Pension Fund's liabilities 
and shall take into account the retirement allow- 
ance arising on account of the additional service 
credit at the earliest age at which the applicant 
could retire on a retirement allowance. 
(1) Eligible applicants who desire to pur- 
chase credit for service under the provi- 
sions of G.S. 58-86-45(al) shall make 
application and acquire certification (as 
necessary) from the eligible fire depart- 
ment or rescue squad on a form designat- 
ed for this purpose. 

TTie phrase "fireman or rescue squad 
worker" as used in G.S. 58-86-45(al) 
shall mean any person who is or was an 
eligible fireman or eligible rescue squad 
worker as defined and provided by G.S. 
58-86-25 and G.S. 58-86-30. 
The phrase "periods of service" as used 
in OS^ 58-86-45(al) shall mean eligible 
service as defined and provided by G.S. 
58-86-25 and G.S. 58-86-30. 
The phrase "not otherwise creditable" as 
used in GJS. 58-86-45(an shall refer to 
eligible service as defined and provided 
by GA 58-86-25 and G.S. 58-86-30 for 



12} 



(3) 



141 



which retirement credit is not currently 
established in Uie Pension Fund. 
(5) The cost to purchase creditable service 
hereunder shall be computed as follows: 

(a) determine amount of service to be 
purchased; 

(b) determine nearest age of a pplicant, 
which for the purposes of this Rule is 
the year and whole month of the age of 
the member; 

(c) determine if an applicant is currently a 
contributing member of tlie Pension 
Fund; 

(d) if applicant is currently a contributing 
member of tlie Pension Fund, multiply 
the cost per year of service (as provided 
by the Pension Fund's consultmg actu- 
ary) at the applicant's nearest age times 
the amount of service to be purchased; 
however, the cost shall not exceed the 
cost as provided under Subitem (5)(e) 
of this Rule for an applicant the same 
age who is not currently a contributing 
member; 

{e} if applicant is not currently a contribut- 
ing member of tlie Pension Fund, ob- 
tain the lump sum amount at the 
applicant's nearest age by referring to 
the present value cost as provided by 
the Pension Fund's consulting actuary; 

(f) the amount of service to be purchased 
in a single transaction shall be all 
eligible service, as defined and 
provided by OS, 58-86-25 and G.S. 
58-86-30. or such portion in ftill years 
as tlie applicant may elect; 

(g) a fee in tlie amount of twenty-five 
dollars ($25.00) for each payment shall 
be assessed members at tlie time of 
purchase as provided by law. 

Statutory Authority G.S 58-86-10; 58-86-45. 

.0218 RETIREMEIVT BENEFITS 

(a) In order to receive retirement benefits under 
G.S. 11 8 4 2 58-86-55 a member must submit to 
the office of the director an application for service 
retirement and the certification of retirement form. 
The applications and certifications will be 
processed at the end of the month; therefore, the 
application and certification must be filed with the 
office of the director at least 30 days prior to the 
last day worked if the applicant is to receive 
retirement benefits by the first of the month 
following his retirement. 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1147 



PROPOSED RULES 



(b) The application for service retirement is used 
to determine when benefits commence and the 
amount of benefits. The signature of the applicant 
must be notarized. The application asks for 
personal identification information including the 
member's name, his register number, age and 
designated beneficiary. 

(c) The certification of retirement form asks the 
retiring member's fire chief or rescue squad 
captain to certify the date of retirement. The form 
asks for personal identification information such as 
the retiree's name, last date of employment, and 
the chiefs or captain's certification of retirement. 

(d) A member who has met all the requirements 
for receipt of a pension as set out jn G.S. 55-86- 
55, and whose 20 years of service as an "eligible 
fireman" or "eligible rescue squad worker" were 
rendered exclusively through volunteer service, 
shall be deemed to be terminated and retired and 
therefore eligible to receive the monthly pension 
provided by G.S. 58-86-55 regardless of any 
capacity in which he/she may be employed or 
reemployed, including salaried positions as firemen 
or rescue squad workers. 

(d) £e] The forms described in Paragraphs (b) 
and (c) of this Rule may be obtained from the 
office of the director at the address shown in Rule 
.0106|e) of this Chapt e r Subchapter . 

Statutory Authority G.S. 58-86-10: 58-86-55. 

TITLE 21 - OCCUPATIONAL 
LICENSING BOARD 

lyiotice is hereby given in accordance with G.S. 
150B-21.2 that the State Board of Refrigeration 
Examiners intends to adopt 21 NCAC 60 .0209, 
.0312 - .0314 and amend rules cited as 21 NCAC 
60 .0101 - .0102, .0207, .1102- .1103. 

1 he proposed effective date of this action is 
December 1, 1993. 

1 he pubUc bearing will be conducted at 10:00 
a.m. on October 12. 1993 at 3716 National Drive, 
Suite 120, Raleigh, NC 27612. 

iVeason for Proposed Action: 

21 NCAC 60 .0101 - clarifies duties of officers. 

21 NCAC 60 .0102 - corrects address. 

21 NCAC 60 .0207 - increases experience and /or 

education required to sit for refrigeration examina- 



tion in order to ensure the protection of the public 
health, comfort and safety. 

21 NCAC 60 .0210 - clarifies expenses for special 
examinations. 

21 NCAC 60 .0312 - requires license be returned 
to Board Office prior to new license being issued. 
21 NCAC 60 .0313 - requires processing fee for 
submittal of bad check. 
21 NCAC 60 .0314 - clarifies use of license. 
21 NCAC 60 .1102 - corrects address. 
21 NCAC 60 .1103 - defines and clarifies disci- 
plinary action that may be taken by the Board. 

i^omment Procedures: All persons interested in 
this matter are invited to attend the public hearing. 
The State Board of Refrigeration Examiners will 
receive mailed written comments postmarked no 
later than October 15, 1993. More information 
may be obtained by contacting the Board Office, 
PO. Box 30693, Raleigh. NC 27622, (919) 781- 
1602. 

CHAPTER 60 - BOARD OF 
REFRIGERATION EXAMINERS 

SECTION .0100 - ORGANIZATION AND 
DEFINITIONS 

.0101 STRUCTURE OF BOARD 

The Board is structured according to G.S. 87-52. 
The Board employs executive director and an 
office secretary. The Chairman, Secretary and 
Treasurer shall be elected at the first regular 
meeting of each year and shall assume office at the 
April meeting following election. It shall be the 
duty of the Chairman to cal] and preside over all 
meetings of the Board and perform such other 
duties as may come within the jurisdiction of 



his/her office. It shall be the duty of the Secretary 
to function as Chairman in the event of his/her 
absence or inability. The Chair of the Board shall 
appoint regular committees to implement pre- 
scribed phases of the Board's functions. The 
Chair shall designate the membership of the 
committees. 



Statutory Authority' G. S 87-52; 87-54. 

.0102 OFFICE OF BOARD 

The Board's office is located at 323 West Morgan 
Str e et, 3716 National Drive, Suite 120, Raleigh, 
North Carolina. The Board's mailing address is 
RO. Box 40§§3 30693, Raleigh, North Carolina 
27605 27622. The Board's rules are available for 



1148 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



PROPOSED RULES 



inspection at this office during regular office 
hours. The materials used in rule-making decisions 
will be available for inspection at said office. 

Statutory Authority G.S. 87-54; 1508-11(2). 

SECTION .0200 - EXAMINATIONS 

.0207 REQUIREMENTS FOR 

EXAMINATION APPLICANTS 

(a) An applicant shall be eligible to take the 
examination upon: 

(1) Filing with the Board an application, on 
a form provided by the Board, together 
with the combined examination-license 
fee. 

(2) Furnishing with his application informa- 
tion satisfactorily verifying that he has 
acquired at least 2900 4000 hours of 
refrigeration experience gained while 
engaged actively and directly in the 
installation, maintenance, servicing or 
repairing of commercial, industrial or 
institutional refrigeration equipment. 
Prior to filing the application, qualify- 
ing experience must be acquired while 
working a minimum of 2000 hours 
under the supervision of a person who 
holds a valid refrigeration contractor's 
license, who is a registered professional 
engineer or who has equivalent industry 
experience. Ug to one-half the experi- 
ence may be in academic or technical 
training directly related to the field of 
endeavor for which examination js 
requested. Applicants who obtain a 
license will receive a certificate issued 
by the Board, bearing that license num- 
ber. The license number shall not be 
assigned or transferred to another indi- 
vidual. 

(b) The deadline for receipt of applications for 
a regular examination shall be six weeks prior to 
the examination date. If an application is received 
after the published deadline, it shall be returned to 
the applicant, and he shall be notified that he may 
apply for and take the next examination. The 
Board, at its discretion, may choose to waive this 
requirement in extenuating circumstances. Tlie 
Board publishes the deadline for application receipt 
in selected newspapers, on posters mailed to all 
refrigeration wholesalers in North Carolina and in 
its quarterly newsletter. 

(c) If a person files an application for examina- 
tion which is accepted, and takes and fails the 



examination, his verification of refrigeration 
experience is kept and is sufficient for taking any 
future examination, provided he files another 
application accompanied by the required fee. 

Statutory Authority G.S. 87-54: 87-58. 

.0210 SPECIAL EXAMINATION 

The expense deposit for a special examination 
pursuant to G.S. 87-58 shall be in an amount 
determined by the Board. After the examination, 
the Board will determine the full cost of the 
examination and refund any balance remaining. 

Statutory Authority G.S 87-54; 87-58(d); 93B- 
8(c). 

SECTION .0300 - LICENSES AND FEES 

.0312 CHANGE OF TRADE NAME 

The trade name under which a license is issued 
may be changed upon request to and approval by 
the Board. The last license issued to the licensee 
must be returned to the Executive Director along 
with the form provided by the Board. 

Statutory Authority G.S. 87-54; 87-60. 

.0313 PROCESSING FEE FOR SUBMITTAL 
OF BAD CHECK 

Any person or firm submitting to the Board a 
check which is subsequently returned to the Board 
because of insufficient funds in or no account at a 
bank will be charged the maximum processing fee 
allowed by G.S. 25-3-512. Until such time as the 
payer of such a bad check has made the check 
good and paid the prescribed processing fee, the 
payer will not be eligible to take an examination, 
obtain a license or have a license renewed. 

Statutory Authority G.S. 87-54; 87-63. 

.0314 USE OF LICENSE 

The licensed contractor shall not permit the use 
of his license by any other person. 

Statutory Authority G.S 87-54; 87-57. 

SECTION .1100 - DISCIPLINARY ACTION 

. 1 1 02 PREFERRING CHARGES 

Any person who believes that any refrigeration 
contractor is in violation of the provisions of G.S. 
87-59 may prefer charges against such contractor 
by setting forth the charges in writing with particu- 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1149 



PROPOSED RULES 



larity including, but not limited to, the date and 
place of the alleged violation. Such charges shall 
be signed and sworn to by the party preferring 
such charges and filed with the Executive Director 
of the State Board of Refrigeration Examiners at 
the office of the Board, 323 We s t Morgan Str e et, 
P.O. Box 10553, 3716 National Drive, P.O. Box 
30693. Raleigh, North Carolina 37605 27622 . 

Statutory Authority G.S. 87-59; 1508-11(1). 

.1103 PRELIMINARY DETERMINATION 

(a) A charge, filed under Rule .1102 of this 
Section, shall be referred initially to a review 
committee. 

(b) The review committee shall be made up of 
the following individuals: 

(1) one officer, other than the Chairman, of 
the State Board of Refrigeration Exam- 
iners. 

(2) the legal counsel of the Board, 

(3) the Executive Director of the State 
Board of Refrigeration Examiners. 

(c) The review committee shall have the authori- 
ty to determine prior to a full Board hearing 
whether or not charges as may be filed against a 
refrigeration contractor are unfounded, frivolous or 
trivial. The determination of the review committee 
shall be final in this respect. 

(d) Once a charge is referred to the review 
committee a written notice of said charge shall be 
forwarded to the licensee against whom the charge 
is made. Notice of the charge and of the alleged 
fects and circumstances surrounding the charge 
shall be given personally or by registered or 
certified mail, return receipt requested. A re- 
sponse to said charges shall be requested of the 
licensee so charged and shall be made within 
twenty days from the date shown on the return 
mail certificate or date of personal notice. 

(e) If the licensee denies the charges brought 
against him, then in the sole discretion of the 
review committee, additional investigative person- 
nel may be retained by the Board for the purpose 
of obtaining evidence relating to such charges. 
The reasonable expenses of any such additional 
personnel shall be borne by the Board. 

(f) After all preliminary' evidence has been 
received by the review committee it shall make a 
preliminary determination of the charges filed 
against the refrigeration contractor. From the 
evidence it may recommend to the Board that: 

(1) the charges be dismissed as unfounded, 
frivolous, trivial; or 

(2) when the charge is admitted by the 



111 



licensee or the evidence warrants, the 
Board issu e a reprimand and ord e r the 
lioeno ee not to commit in tho future the 
sp e cific act or acts admittod by him to 
have b ee n in violation of any of tho 
provisions of G.S. — 8 7 59, 8 7 57, or 
8 7 61 ; or be presented with the charge 
for its decision. If the charge is of 
such gravity as to make the imposition 
of punitive sanctions likely, the Board 
may administer one or more of the 
following penalties if the licensee is 
found to be guilty as prescribed by law: 
Reprimand; 

Suspension from practice for a period 
not to exceed 12 months; 
Probationary revocation of license 
upon conditions set by the Board as 
the case shall warrant with revocation 
upon failure to comply with the condi- 
tions; or 
(D) Revocation of license. 
(3) if the charge is denied and evidence 
warrants, or if the charge, while admit- 
ted, is of such gravity as to make the 
imposition of punitive sanctions likely, 
the charge be presented to the Board 
for its decision on the merits of the 
charge in accordance with the statutes 
governing contested cases. 
In connection with any such reprimand and subse- 
quent order the Board may also provide that in the 
event the licensee is determined to have violated in 
the future any of the aforementioned statutes the 
Board may suspend or revoke his license as pre- 
scribed by law. 

Statutory- Authority G.S. 87-57; 87-59; 1508-11(1). 



1150 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



RRC OBJECTIONS 



1 he Rules Review Commission (RRC) objected to the following rules in accordance with G.S. 
143B-30.2(c). State agencies are required to respond to RRC as provided in G.S. 143B-30.2(d). 



ADMINISTRATION 

Department of Administration's Minimum Criteria 

1 NCAC 39 .0101 - Purpose 

No Response from Agency 

Agency Responded 
1 NCAC 39 .0301 - Exceptions to Minimum Criteria 

No Response from Agency 

Agency Responded 

Low-Level Radioactive Waste Management Authority 

1 NCAC 37 . 0306 - Preferred Site 
Agency Revised Rule 

COMMERCE 



RRC Objection 
Obj. Contd 
Obj. Contd 
RRC Objection 
Obj. Contd 
Obj. Contd 



RRC Objection 
Obj. Removed 



06/17/93 
07/15/93 
08/20/93 
06/17/93 
07/15/93 
08/20/93 



08/20/93 
08/20/93 



Banking Commission 

4 NCAC 3J .0204 - Application for Renewal of Certificate of Registration 

Agency Revised Rule 
4 NCAC 3J . 0302 - Record and Bookkeeping Requirements 

Agency Revised Rule 

COMMUNITY COLLEGES 
Community Colleges 

23 NCAC 2C .0105 - Establishing Colleges 

Agency Revised Rule 
23 NCAC 2D .0202 - Curriculum 

Agency Revised Rule 
23 NCAC 2D .0203 - Extension Programs 

Agency Revised Rule 
23 NCAC 2D .0304 - Expenditures /State Funds: Accreditation Expenses & Dues 

Agency Withdrew Rule 
23 NCAC 2D .0305 - Expenditure of State Funds: Postage Machines 

Agency Revised Rule 
23 NCAC 2D .0307 - Expenditure of State Funds: Certificate Costs 

Agency Withdrew Rule 
23 NCAC 2D .0309 - Expenditure of State Funds: Travel and Allowances 

Agency Withdrew Rule 
23 NCAC 2D .0310 - Live Projects 

Agency Re\'ised Rule 
23 NCAC 2D .031 1 - Handling Overhead Receipts and Allowances 

Agency Withdrew Rule 



RRC Objection 08/20/93 

Obj. Removed 08/20/93 

RRC Objection 08/20/93 

Obj. Removed 08/20/93 



RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 




08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 




08/20/93 




08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 



08/20/93 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1151 



RRC OBJECTIONS 



23 NCAC 2D .0312 - Bookstore: Vending Machine 

Agency Revised Rule 
23 NCAC 2D .0313 - Acquisition of Automated Data Processing Resources 

Agency Withdrew Rule 
23 NCAC 2D .0318 - Equipment Budget Requests: Distribution of Funds 

Agency Re\'ised Rule 
23 NCAC 2D .0319 - Allotment Procedures for Human Resources Development 

Agency Withdrew Rule 
23 NCAC 2D .0320 - Library Book Funding System & Budgetary Application 

Agency Revised Rule 
23 NCAC 2D . 0321 - Payroll Deduction 

Agency Withdrew Rule 
23 NCAC 2D .0323 - Reporting of Student Hrs/Membership/Curriculum Classes 

Agency Rex'ised Rule 
23 NCAC 2D .0324 - Rept/Stu Hrs/Membership/Extension (Non-Credit) Classes 

Agency Revised Rule 
23 NCAC 2D .0601 - Appropriation Requests and Allocation Policy' 

Agency Re\'ised Rule 
23 NCAC 2D .0602 - Capital Project Approval and Obtaining Capital Funds 

Agency Re\ised Rule 
23 NCAC 2E .0101 - Program Classification 

Agency Re\ised Rule 
23 NCAC 2E .0102 - Curriculum Programs: Degrees, Diplomas, Certificates 

Agency Re\'ised Rule 
23 NCAC 2E .0201 - Establishing or Terminating Curriculums 

Agency Rexised Rule 
23 NCAC 2E .0203 - Standards for Technical-Vocational Curriculums 

Agencv Withdrew Rule 



RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 




08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 




08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 




08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 


RRC Objection 


08/20/93 


Obj. Removed 


08/20/93 




08/20/93 



General Provisions 



23 NCAC lA .0001 - Definitions 
Agency Rexised Rule 

23 NCAC lA .0003 - Authority- 
Agency Rexised Rule 



RRC Objection 08/20/93 

Obj. Removed 08/20/93 

RRC Objection 08/20/93 

Obj. Removed 08/20/93 



ENVIRONMENT, HEALTH, AND NATURAL RESOLTiCES 
Environmental Management 



15A NCAC 2H .1110 - Implementation 
Agency Responded 
Agency Responded 
Agency Responded 
Agency Responded 
No Response from Agency 



RRC Objection 


02/18/93 


Obj. 


Cont d 


03/18/93 


Obj. 


Cont d 


05/19/93 


Obj. 


Cont d 


06/17/93 


Obj. 


Cont d 


07/15/93 


Obj. 


Cont d 


08/20/93 



Solid Waste Management 



15A NCAC 13B .1604 - General Requirements for MSWLF Facilities 

Agency Rexised Rule 
15A NCAC 13B . 1618 - Site Study for MSWLF Facilities 

Agency Rexised Rule 
15A NCAC 13B .1622 - Location Restrictions for MSWLF Facility Siting 

Agency Rexised Rule 



RRC Objection 
Obj. RenwveJ 
RRC Objection 
Obj. Removed 
RRC Objection 
Obj. Removed 



08/20/93 
08/20/93 
08/20/93 
08/20/93 
08/20/93 
08/20/93 



1152 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



RRC OBJECTIONS 



15A NCAC 13B . 1624 - Construction Requirements for MSWLF Facilities RRC Objection 08/20/93 

Agency Revised Rule Obj. Removed 08/20/93 

15A NCAC 138 . 1626 - Operational Requirements for MSWLF Facilities RRC Objection 08/20/93 

Agency Revised Rule Obj. Removed 08/20/93 

15A NCAC 13B . 1635 - Assessment of Corrective Measures RRC Objection 08/20/93 

Agency Revised Rule Obj. Removed 08/20/93 

HUMAN RESOURCES 

Children's Services 

10 NCAC 41 R .0002 - Administration and Organization RRC Objection 07/15/93 

Agency Responded Obj. Cont'd 08/20/93 

LICENSING BOARDS AND COMMISSIONS 

Landscape Architects 

21 NCAC 26 .0203 - General Obligations of Practice: Mandatory Standards RRC Objection 06/17/93 

Agency Repealed Rule Obj. Removed 06/1 7/93 

21 NCAC 26 . 0205 - Forms of Practice RRC Objection 06/1 7/93 

Rule Returned to Agency 07/15/93 

21 NCAC 26 . 0207 - Application of Professional Seal RRC Objection 06/1 7/93 

Rule Returned to Agency 07/15/93 

21 NCAC 26 .0208 - Improper Conduct RRC Objection 06/17/93 

Rule Returned to Agency 07/15/93 

21 NCAC 26 .0209 - Unprofessional Conduct RRC Objection 06/17/93 

Agency Revised Rule Obj. Removed 07/15/93 

21 NCAC 26 .0210 - Dishonest Practice RRC Objection 06/17/93 

Agency Revised Rule Obj. Removed 07/15/93 

21 NCAC 26 .0211 - Incompetence RRC Objection 06/17/93 

Agency Revised Rule Obj. Retnoved 07/15/93 

21 NCAC 26 .0301 - Examination RRC Objection 06/17/93 

Agency Revised Rule Obj. Removed 07/15/93 

Pharmacy 



21 NCAC 46 .1809- Emergency Prescription Refills 
Agency Rexised Rule 



RRC Objection 
Obj. Removed 



08/20/93 
08/20/93 



Social Work 

21 NCAC 63 .0201 - Definitions 

Agency Revised Rule 
21 NCAC 63 .0210 - Provisional Certificates 

Agency Revised Rule 
21 NCAC 63 .0501 - Introduction 

Agency Withdrew Rule 

REVENUE 

Sales and Use Tax 



RRC Objection 
Obj. Removed 
RRC Objection 
RRC Objection 



08/20/93 
08/20/93 
08/20/93 
08/20/93 

08/20/93 



17 NCAC 7B .0902 - Advertising Artists: Paste-Ups and Mechanicals 
Agency Revised Rule 



RRC Objection 
Obj. Removed 



08/20/93 
08/20/93 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1153 



RRC OBJECTIONS 



17 NCAC 7B .0904 - Public Relation Firms 
Agency Revised Rule 



RRC Objection 
Obj. Removed 



08/20/93 
08/20/93 



i 



{ 



i 



1154 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



RULES INVALIDATED BY JUDICIAL DECISION 



1 his Section of the Register lists the recent decisions issued by the North Carolina Supreme Court, 
Court of Appeals, Superior Court (when available), and the Office of Administrative Hearings which 
invalidate a rule in the North Carolina Administrative Code. 



1 NCAC 5A .0010 - ADMINISTRATIVE PROCEDURES 

TTiomas R. West, Administrative Law Judge with the Office of Administrative Hearings, declared two portions 
of Rule 1 NCAC 5A .0010 void as applied in Stauffer Information Systems, Petitioner v. TTie North Carolina 
Department of Community Colleges and The North Carolina Department of Administration, Respondent and 
The University of Southern California, Intervenor-Respondent (92 DOA 0666). 

10 NCAC 3H .0315(b) - NURSING HOME PATIENT OR RESIDENT RIGHTS 

Dolores O. Nesnow, Administrative Law Judge with the Office of Administrative Hearings, declared Rule 10 
NCAC 3H .0315(b) void as applied in Barbara Jones, Petitioner v. North Carolina Department of Human 
Resources, Division of Facility Services, Licensure Section, Respondent (92 DHR 1192). 

10 NCAC 3R .1124(0 - ACCESSIBILITY TO SERVICES 

Beecher R. Gray, Administrative Law Judge with the Office of Administrative Hearings, declared Rule 10 
NCAC 3R .1124(f) void as applied in Britthaven, Inc. dfbia Britthaven of Morganton, Petitioner v. N.C. 
Department of Human Resources, Division of Facility Services, Certificate of Need Section, Respondent and 
Valdese Nursing Home, Inc., Respondent-Intervenor (92 DHR 1785). 

15A NCAC 30 .0201(a)(1)(A) - STDS FOR SHELLFISH BOTTOM & WATER COLUMN LEASES 

Julian Mann IIL Chief Administrative Law Judge with the Office of Administrative Hearings, declared Rule 
15A NCAC 30 .0201(a)(1)(A) void as applied in William R. Willis, Petitioner u North Carolina Division of 
Marine Fisheries, Respondent (92 EHR 0820). 

ISA NCAC 19A .0202(d)(10) - CONTROL MEASURES - HIV 

Brenda B. Becton, Administrative Law Judge with the Office of Administrative Hearings, declared Rule 15A 
NCAC 19A .0202(d)(10) void as applied in ACT-UP TRIANGLE (AIDS Coalition to Unleash Power Triangle), 
Steven Harris, and John Doe, Petitioners v. Commission for Health Services of the State of North Carolina, 
Ron Levine, as Assistant Secretary of Health and State Health Director for the Department of Environment , 
Health, and Natural Resources of the State of North Carolina, William Cohey, as Secretary of the Department 
of Environment, Health, and Natural Resources of the State of North Carolina, Dr. Rebecca Meriwether, as 
Chief Communicable Disease Control Section of the North Carolina Department of Environment , Health, and 
Natural Resources, Wiyne Babbitt Jn , as Chief of the HIV/SID Control Branch of the North Carolina 
Department of Environment, Health, and Natural Resources, Respondents (91 EHR 0818). 



8:12 NORTH CAROLINA REGISTER September 15, 1993 1155 



CONTESTED CASE DECISIONS 



1 his Section contains the full text of some of the more significant Administrative Law Judge decisions 
along with an index to all recent contested cases decisions which are filed under North Carolina 's 
Administrative Procedure Act. Copies of the decisions listed in the index and not published are available 
upon request for a minimal charge by contacting the Office of Administrative Hearings, (919) 733-2698. 



i 



AGENCY 



CASE 
NUMBER 



ALJ 



DATE OF 
DECISION 



PUBLISHED DECISION 
REGISTER CITATION 



ADMINISTRATION 

LMS Express. Inc. v. Administration. Di\- of Purchase & Contract 
Stauffer Information Systems v. Community Colleges & Admmistration 
McLauiin Parking Co. v. Administration 
Warrcn H. Arrington Jr. v. Division of Purchase & Contract 

ALCOHOLIC BEVERAGE CONTROL COMMISSION 



92 DOA 0735 


Morgan 


06/04/93 




92 DOA 0803 


West 


06/10/93 


8:7 NCR 613 


92 DOA 1662 


Morrison 


04/02/93 


8:3 NCR 320 


93 DOA 0132 


West 


07/21/93 





Alcoholic Bes'erage Control Comm. v. Ann Oldham McDos>.cIl 
Curtis Rfl)' Lynch v. Alcoholic Be\'erage Control Comm. 
Alcoholic Beverage Control Comm. v. Ezra Everett Rigsbec 
Alcoholic Be\erage Control Comm. v. Partneiship. Phillip Owen Edaand 
Alcoholic Be\erage Control Comm. v. Garv Morgan Neugent 
Alcoholic Be\'erage Control Comm. v. KirK Ronald Eldric^e 
Alcoholic Beverage Control Comm. \'- Gloria Black McDuffie 
Alcoholic Be^'erage Control Comm. v. Lam Isacc Hailstock 
Alcoholic Beverage Control Comm. v, Anthony Ralph Cecchini Jr, 
Johnnie L. Baker v. Alcoholic Be%erage Control Commission 
RAAISAC Enterprises, Inc. v. Alcoholic Beverage Control Comm. 
Alcoholic Beverage Control Comm. v. Aubrey Rudolph Wallace 
Alcoholic Bev'erage Control Comm. v. Mermaid. Inc. 
Alcoholic Beverage Control Comm. v. Majdi Khalid Wahdan 
Cornelius Hines T/A Ebonv Lounge v. Alcoholic Beverage Ctl. Comm. 
Alcoholic Beverage Control Comm. v. Homer Patrick Godwin Jr. 
Alcoholic Beverage Control Comm. v. Wanda Lou Ball 
Charles Anthonious Morant v. Alcoholic Beverage Control Conun. 
Alcoholic Beverage Control Comm. v. Billy Fincher McS^ain Jr. 
ABC Comm. v. I^rlner5hip/T''A Corrolheis Comty Ctr &. Private Club 
Alcoholic Beverage Control Comm. v. James Elvwod Alphin 
Alcoholic Beverage Control Comm. v. James ^Mlliam Campbell 
Alcoholic Beverage Control Comm. v. Richard Donald James Jr 
Charles EdiAaid Hare. Club Paradise v. Alcoholic Beverage Ctl. Comm. 
Alcoholic Bev. Control Comm. v. Mild & Wild, Inc.. Sheila Scholz 



92 ABC 0260 


Morgan 


04/01/93 


92 ABC 0288 


Gray 


05/18/93 


92 ABC 0702 


West 


07/30/93 


92 ABC 0978 


Gra\ 


05/28/93 


92 ABC 1086 


Beclon 


03/22/93 


92 ABC 1153 


Chess 


04/26/93 


92 ABC 1476 


West 


05/26/93 


92 ABC 1483 


Reilly 


04/07/93 


92 ABC 1690 


Morgan 


06/29/93 


92 ABC 1735 


Chess 


05/07/93 


93 ABC 0002 


Morrison 


07,'02/93 


93 ABC 0047 


Grav" 


05/28/93 


93 ABC 0076 


Grav- 


08/04/93 


93 ABC 0087 


Bee ton 


07/06/93 


93 ABC 0118 


Morrison 


08/04/93 


93 ABC 0125 


Reillv 


05/13/93 


93 ABC 0182 


Nesnoft' 


07/29/93 


93 ABC 0232 


Chess 


07/20/93 


93 ABC 0239 


Gray 


08/26/93 


93 ABC 0318 


Reilly 


07/22/93 


93 t<BC 0326 


Gray- 


08/26/93 


93 ABC 0327 


Gray 


08/09/93 


93 ABC 0431 


Nesnoft' 


09/01/93 


93 ABC 0644 


Gray 


08/10/93 


93 ABC 1475 


Nesnoft' 


03/23/93 



8:9 NCR 785 



{ 



COMMERCE 

Lester Moore v. Weatherizalion Assistance Program 
CRIME CONTROL .\ND PUBLIC SAFETY 



93 COM 0105 Grav 



03/08/93 



George W. F^lor v. Crime Victims Compensation Comm. 
Steven A. Bamer v. Crime Victims Compensation Comm. 
Anlhorr. L. Hart v. Victims Compensation Cormn. 
Jeimifer Ayers v. Crime Victims Compensation Comm. 
Janie L. Howard v. Crime Victims Compensation Comm. 
Isabelle Hyman v. Crime Victims Compensation Comm. 
James G. Pellom v. Crime Control & Public Safety 
Norman E. Brown v. Victims Compensation Commission 
Moses H. Cone Mem Hosp v. Victims Compensation Comm. 
David &. Jane Spano v. Crime Control &. I^ublic Safety 
Phillip Edward Moore v. Crime Control &. Public Safely 
Norma Jean Purkett v. Crime Victims Compensation Coram. 
Sheila Carter v. Crime Control and Public Safety 
John VVIllie Leach v. Crime Victims Compensation Comm. 
Nellie R. Mangum v. Cnme Victims Compensation Comm. 
Constance Brown v. Crime Victims Compensation Comm. 



91 CPS 1286 


Morgan 


04,'27.'93 




92 CPS 0453 


Nesnow 


06/01 '93 




92 CPS 0937 


Chess 


03,'01,'93 




92 CPS 1195 


Reillv 


03/19/93 




92 CPS 1787 


Reillv 


03/26/93 




92 CPS 1807 


Morrison 


05,'24/93 




93 CPS 0034 


Gray- 


05/05,'93 




93 CPS 0141 


West 


07/07/93 




93 CPS 0152 


Nesnow. 


04/02.'93 


8:3 NCR 327 


93 CPS 0160 


Nesncm- 


07/30/93 


8:10 NCR 862 


93 CPS 0169 


Nesnoft- 


05/20/93 




93 CPS 0205 


West 


08/27/93 


8:12 NCR 1171 


93 CPS 0249 


Morgan 


08.'25/93 




93 CPS 0263 


Morrison 


05/20/93 




93 CPS 0303 


Morrison 


06/08/93 




93 CPS 0351 


Reillv 


05.'24/93 





i 



1156 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



CONTESTED CASE DECISIONS 



AGENCY 



CASE 
NUMBER 



ALJ 



DATE OF 
DECISION 



PUBLISHED DECISION 
REGISTER CITATION 



ENVIRONMENT, HEALTH, AND NATURAL RESOURCES 



Charles L. Wilson v. Environment, Health, & Natural Resources 
J. Bruce Mulligan v. Environment, Health, & Nalmal Resources 
Michael D. BatTies v. Onslow Cty Hlth & Environment and EHR 
William E. Finck v. Environment, Health, & Natural Resources 
Utley C. Stallings v. Environment, Health, & Natural Resources 
A.J. Ballard Jr., Tire & Oil Co., Inc. v Env., Health, & Nat. Res. 
Safeway Remwal, Inc. v. EnvitDnment, Health, & Natural Res. 
Elizabeth City/Itequotank Cty Mun Airport Auth v. EHNR 
Interstate Brands Corp & Donald Letfew v. Env., Health, & Nat. Res. 
Service Oil Company v. Environment, Health, & Natural Resources 
Interstate Brands Corp & Donald Letfew v. Env., Health, & Nat. Res. 
Residents of Camm & Shell v. Health Envirrtnmental - Septic Tank Div. 
City of Salisbury v. Envirx)nment, Health, & Natural Resources 
Wrllie M. Watford v Hertfonl Gates District Health Department 
Standard Speciality Contractors, Inc. v. EHNR 
Shawqi A. Jaber v. Envitx>nment, Health, & Natural Resources 
Angela PDwer, Albert Power v. Children's Special Health Svcs. 
Erby Lamar Grainger v. Environment, Health, & Natural Resources 
Mustafa E. Essa v. Envirx:inment, Health, & Natural Resources 
Charlie Garfield McPherson Swine Farm v. Env., Health, tfe Nat. Res. 
Rosetta Brimage, Vanessa I^ck v. Errv. Health of Craven County 
R.L. Stowe Mills, Inc. v. Environment, Health, & Natural Resources 
O.C. Staffoni/Larry Haney v. Montgomery Cty. Health Dept. 
Fred M. Grooms v. Environment, Health, &. Natural Resources 
Bobby Anderson v. Environment, Health, & Natural Resources 
Shell BrTDs. Dist., Inc. v. Errvironment, Health, & Natural Resources 
Fred C. Gosnell & wife, Patricia T. Gosnell v. Env., Health, & Nat. Res. 
Holding Bros., Inc. v. Errvironment, Health, & Natural Resources 
Hamilton Beach/Proctor-Silex, Inc. v. Environment, Health, & Natrl Res 



91 EHR 0664 


Morgan 


03/23/93 




91 EHR 0773 


West 


07/13/93 




91 EHR 0825 


Morgan 


06/21/93 




92 EHR 0040 


Gray 


06/14/93 




92 EHR 0062 


Gray 


03/15/93 




92 EHR 0754 


Nesnow 


08/30/93 




92 EHR 0826 


West 


03/12/93 


8:1 NCR 83 


92 EHR 1140 


Gray 


04/13/93 




92 EHR 1201*" 


Reilly 


08/12/93 




92 EHR 1205 


Reilly 


05/27/93 




92 EHR 1224*" 


Reilly 


08/12/93 




92 EHR 1462 


Morrison 


08/25/93 




92 EHR 1472 


Morrison 


04/22/93 




92 EHR 1600 


Chess 


03/24/93 




92 EHR 1660 


Reilly 


05/21/93 




92 EHR 1784 


Bee ton 


07/07/93 




93 EHR 0008 


Becton 


03/24/93 




93 EHR 0071 


Reilly 


06/21/93 




93 EHR 0146 


Gray 


03/29/93 




93 EHR 0181 


Reilly 


07/23/93 


8:10 NCR 870 


93 EHR 0206 


Nesnow 


05/20/93 




93 EHR 0219 


Morrison 


08/11/93 


8:11 NCR 996 


93 EHR 0224 


Gray 


06/07/93 




93 EHR 0276 


West 


08/27/93 


8:12 NCR 1176 


93 EHR 0299 


Reilly 


06/07/93 




93 EHR 0308 


Becton 


05/18/93 




93 EHR 0340 


Becton 


08/11/93 




93 EHR 0380 


Nesnow 


08/03/93 


8:11 NCR 1001 


93 EHR 0477 


Reilly 


06/29/93 





HUMAN RELATIONS COMMISSION 



Human Relations Comm. on behalf of Marsha Crisco v. Hayden Morrison 93 HRC 0167 
HUMAN RESOURCES 



Reilly 



08/18/93 



8:12 NCR 1168 



O.C. Williams v. Human Resourc'es 

Ronald Terry Brown v. Human Resources 

Dennis K. King v. Human Resources 

Cathy Harris, A/K/A Cathy D. Grubb v. Human Resources 

Raymond L. Griffin v. Human Resources 

O.C. WtUiams v. Human Resources 

Michael L. Ray v. Human Resources 

Randy Chambliss v. Human Resources 

Melvin While v. Human Resources 

Joseph R. Kavaliauskas Jr. v. Human Resources 

Larry D. Boyd v. Human Resources 

Jefferson D. Bcylen v. Human Resources 

Jeffery D. Williams v. Human Resources 

Jerry L. Summers v. Human Resources 

Samuel E. Massenber^ Jr. v. Human Resources 

Wrlliam A. Dixon v. Human Resources 

Gregory L. Washington v. Human Resources 

Edwin Clarke v. Human Resources 

Dwayne Allen v. Human Resources 

Edwin Ivester v. Human Resources 

Connie F. Epps, Otis Junior Epps v. Human Resources 

Tyrone Aiken v. Human Resources 

Everett M. Eaton v. Human Resources 

Edward E. Brandon v. Human Resources 

Darrell W. Russell v. Human Resources 

John Henry Bynd v. Human Resources 



91 CSE 
91 CSE 
91 CSE 
91 CSE 
91 CSE 
91 CSE 
91 CSE 
91 CSE 
91 CSE 
91 CSE 
91 CSE 
91 CSE 
91 CSE 
91 CSE 
91 CSE 

91 CSE 

92 CSE 
92 CSE 
92 CSE 
92 CSE 
92 CSE 
92 CSE 
92 CSE 
92 CSE 
92 CSE 
92 CSE 



0036*- 

0249 

1122 

1131 

1148 

1158*= 

1173 

1187 

1192 

1204 

1214 

1217 

1231 

1234 

1249 

1277 

0075 

0129 

0196 

0268 

1182 

1217 

1221 

1237 

1249 

1250 



Morgan 

Morgan 

Morgan 

Morgan 

Morgan 

Morgan 

Morgan 

Morgan 

Morgan 

Morgan 

Morgan 

Morgan 

Morgan 

Morgan 

Morgan 

Morrison 

Morgan 

Morgan 

Morgan 

Nesnow 

Reilly 

Gray 

Reilly 

Gray 

Becton 

Reilly 



03/30/93 
05/17/93 
07/28/93 
08/24/93 
08/24/93 
03/30/93 
05/17/93 
04/28/93 
05/17/93 
07/29/93 
08/24/93 
05/17/93 
04/28/93 
07/28/93 
05/17/93 
03/04/93 
04/01/93 
05/17/93 
03/31/93 
03/30/93 
07/22/93 
06/17/93 
07/27/93 
04/16/93 
04/20/93 
06/04/93 



Consolidated cases. 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1157 



CONTESTED CASE DECISIONS 



AGENCY 



Michelle D. Mobl^ v. Human Resources 
Gus W. Long Jr. v. Human Resources 
Robert E. Watson v. Human Resources 
Byron Christopher Williams v. Human Resources 
James W. Bell v. Human Resources 
Charies W. Stall Jr. v. Human Resources 
Eric Stanley Stokes v. Human Resources 
Frank E. Johnson v. Human Resources 
David Rollins V. Human Resources 
Lyndell Greene v. Human Resources 
Michael Anthony Dean v. Human Resources 
Leroy Snuggs v. Human Resources 
James R Miller III v. Human Resources 
Herbert H- FonJham v. Human Resources 
Jack Dulq v. Human Resources 
Larry L. Crowder v. Human Resources 
Carlos Bernard Davis v. Human Resources 
Ocie C. Williams v. Human Resources 
Terrance Freeman v. Human Resources 
Floyd Excell Stafford v. Human Resources 
Timothy Brian EUer v. Human Resources 
Charies S. Ferrer v. Human Resources 
Ronald H. Lockley v. Human Resources 
Rene Thomas Rittenhouse v. Human Resources 
Thomas EdiAQnJ Williamson v. Human Resources 
Roy Chester Robinson v. Human Resources 
Timothy Scott Long v. Human Resources 
David W, Williams v. Human Resources 
William E. Ingram v, Human Resources 
Harold R. Pledger v. Human Resources 
Henry Alston Jr. v. Human Resources 
Michael W, Bentl^ v. Human Resources 
Dale Robert Stuhre v. Human Resources 
James T. Carter Jr. v. Human Resources 
Tommy Malone v. Human Resources 
James C. Dixon Jr. v. Human Resources 
Wallace M. Cooper v. Human Resources 
Jarvis N. Price v. Human Resources 
Thomas L. Yates v. Human Resources 
Robert E. Tarlton Sr. v. Human Resources 
Rodney Devard Clemons v. Human Resources 
James A. Coleman v. Human Resources 
Romeo F Skapple v. Human Resources 
Jeffrey L. Garrett v. Human Resources 
Edward Kirk v. Human Resources 
William C. Hubbard v. Human Resources 
William Michael Przytysz v. Human Resources 
Ed\vand Rtch v. Human Resources 
David Robinette v. Human Resources 
Kit C. Elmorc v. Human Resources 
Brian C. Gilmore v. Human Resources 
Philip S. Piercy v. Human Resources 
Anthoi^ McLaughlin v. Human Resources 
Johnny W, Cooke v. Human Resources 
Roland L. Essaff v. Human Resources 
Isaac Maxwell v. Human Resources 
Donald J. Ray v. Human Resources 
Charles Wayne Pierce v. Human Resources 
Donna G. Knotts v. Human Resources 
Donald R. Williams v. Human Resources 
McKinl"^ Clybum V, Human Resources 
Torty Thorpe v. Human Resources 
Jeffer> D. Williams v. Human Resources 
Ronald Sowell v. Human Resources 
Billy Smith v. Human Resources 
Anthorty Curry v. Human Resources 
John G. Williams v. Human Resources 
Larry W. Golden v. Human Resources 



CASE 




DATE OF 


NUMBER 


ALJ 


DECISION 


92 CSE 1256 


Nesnow 


04/15/93 


92 CSE 1263 


Gray 


08/16/93 


92 CSE 1265 


Reilly 


05/06/93 


92 CSE 1270 


Nesnow 


04/26/93 


92 CSE 1311 


Nesnow 


05/10/93 


92 CSE 1313 


Mann 


07/06/93 


92 CSE 1316*' 


Reilly 


03/25/93 


92 CSE 1326 


Reilly 


08/16/93 


92 CSE 1334 


Morrison 


05/06/93 


92 CSE 1346 


Nesnow 


04/16/93 


92 CSE 1356 


Morrison 


08/13/93 


92 CSE 1360 


Morrison 


04/15/93 


92 CSE 1361 


Gray 


04/16/93 


92 CSE 1362 


Nesnow 


07/19/93 


92 CSE 1374 


Gray 


07/16/93 


92 CSE 1396 


Reilly 


04/15/93 


92 CSE 1404 


Reilly 


04/15/93 


92 CSE 1405 


Mann 


06/25/93 


92 CSE 1411 


Mann 


06/07/93 


92 CSE 1412 


Reilly 


08/31/93 


92 CSE 1414 


Reilly 


04/20/93 


92 CSE 1416 


Mann 


04/15/93 


92 CSE 1418 


Nesnow 


04/20/93 


92 CSE 1421 


Nesnow 


04/20/93 


92 CSE 1422 


Reilly 


04/20/93 


92 CSE 1423 


Reilly 


04/15/93 


92 CSE 1445 


Becton 


06/29/93 


92 CSE 1448 


Nesnow 


07/19/93 


92 CSE 1450 


Reilly 


04/15/93 


92 CSE 1455 


Morrison 


05/20/93 


92 CSE 1460 


Bee Ion 


06/29/93 


92 CSE 1512 


Nesnow 


06/09/93 


92 CSE 1516 


Reilly 


05/11/93 


92 CSE 1517 


Mann 


08/31/93 


92 CSE 1520 


Mann 


05/07/93 


92 CSE 1522 


Becton 


05/11/93 


92 CSE 1527 


Reilly 


05/11/93 


92 CSE 1531 


Morrison 


05/12/93 


92 CSE 1535 


Gray 


05/10/93 


92 CSE 1536 


Gray 


05/17/93 


92 CSE 1539 


Gray 


05/10/93 


92 CSE 1540 


Reilly 


05/11/93 


92 CSE 1545 


Gray 


04/26/93 


92 CSE 1557 


Gray 


04/22/93 


92 CSE 1560 


Gray 


06/29/93 


92 CSE 1562 


Mann 


05/12/93 


92 CSE 1565 


Becton 


07/23/93 


92 CSE 1572 


Reilly 


05/11/93 


92 CSE 1573 


Mann 


07/14/93 


92 CSE 1575 


Gray 


07/16/93 


92 CSE 1576 


Gray 


04/26/93 


92 CSE 1577 


Gray 


07/16/93 


92 CSE 1582 


Gray 


06/29/93 


92 CSE 1585 


Becton 


05/11/93 


92 CSE 1588 


Morrison 


07/26/93 


92 CSE 1589 


Re illy 


04/26/93 


92 CSE 1592 


Mann 


05/19/93 


92 CSE 1596 


Morrison 


07/14/93 


92 CSE 1611 


Morrison 


07/16/93 


92 CSE 1622 


Nesnow 


08/04/93 


92 CSE 1623 


Morrison 


05/20/93 


92 CSE 1625 


Chess 


07/15/93 


92 CSE 1626 


Mann 


05/19/93 


92 CSE 1627 


Reilly 


07/19/93 


92 CSE 1629 


Reilly 


03/25/93 


92 CSE 1631 


Reilly 


03/25/93 


92 CSE 1532 


Mann 


08/10/93 


92 CSE 1633 


Reilly 


03/25/93 



PUBLISHED DECISION 
REGISTER CITATION 



1158 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



CONTESTED CASE DECISIONS 



AGENCY 



William J. Carter v. Human Resources 

Mark W. Dean v. Human Resources 

Tyrone Thomas v. Human Resources 

Rillon E. May v. Human Resources 

Eric Stanley Stokes v. Human Resources 

Larry Thompson v. Human Resources 

Billie J. Smith v. Human Resources 

Patrick Royd v. Human Resources 

Dennis W. Nolan v. Human Resources 

Eric L. Gariand v. Human Resources 

Ira Alston Jr. v. Human Resources 

Ronald G. Bolden v. Human Resources 

Marvin HoUty v. Human Resources 

Eddie Short v. Human Resources 

Michael Tywan Marsh v. Human Resources 

Leroy Jones v. Human Resources 

Joseph Eric Lewis v. Human Resources 

Ronald Dean Lowery v. Human Resources 

James E. Blakney v. Human Resources 

Oswinn Blue v. Human Resources 

Kelvin D. Jackson v. Human Resources 

Linwood Staton v. Human Resources 

Anthoi^ Watson v. Human Resources 

Eugene Palk v. Human Resources 

Barbara W. Catlett v. Human Resources 

Laurel Langford v. Human Resources 

Ida Diane Davis v. Human Resources 

Halsuko Klein v. Human Resources 

Karen Mullins Martin v. Human Resources 

Leon Barbec v. Human Resources 

Carrolton of Dunn. Inc. v. Human Resources 

Dia!>«is Care of North Carolina. Inc., d/b/a Dialysis Care of 
Cumberland County v. Human Resources, Division of Facility 
Services, Certificate of Need Section, and Bio-Medical 
Applications of F^etteville d/b/a F^etteville Kidney Center, 
Webb-Loha/ichan-Melton Rentals, Bio-Medical Applications 
of North Carolina, Inc., d/b/a BMA of Raefond and Webb- 
Loha^ichan Rentals 

Dialysis Care of North Carolina, Inc., d/b/a Dialysis Care of 
Cumberland County v. Human Resourc^es, Division of Facility 
Services, Certificate of Need Section, and Bio-Medical 
Applications of Fayetteville d/b/a F^etteville Kidni^ Center, 
Webb-Loha/ichan-Melton Rentals, Bio-Medical Applications 
of North Carolina, Inc., d/b/a BMA of Raefond and Webb- 
Lohavichan Rentals 

Bio-Medical Applications of North Carolina, Inc.. d/b/a BMA 
of Raeford, Webb- Loha/ichan- Me lion Rentals, Bio-Medical 
Applications of North Carolina, Inc., d/b/a BMA of Fayetteville 
d/b/a Fayetteville Kidn^ Center and Webb-Loha-'ichan Rentals 
V. Human Resources. Division of Facility Services, Certificate of 
Need Section and Dialysis Care of North Carolina, Inc.. d/b/a 
Dialysis Care of Hoke County 

Renal Care of Rocky Mount, Inc. v. Human Resources, Division of 
Facility Services, Certificate of Need Section, and Bio-Medical 
Applications of North Carolina, Inc., d/b/a BMA of Tarboro, 
Rocky Mount Nephrology Associates, Inc., Bio-Medical 
Applications of North Carolina, Inc., d/b/a BMA of Rocky Mount 
d/b/a Rocky Mount Kidnt^ Center, and Rocky Mount Kidney Center 
Associates 

James H. Hunt Jr. v. Division of Medical Assistance 

Barbara Jones v. Human Resources 

Joyce P. Williams v. Human Resources 

Snoopy Day Care, Diane Hamby v. Child Day Care Licensing 

Cynthia Reed v. Human Resources 

The Neighborhood Center v. Human Resources 

Helm's Rest Home, Ron J. Schimpf/Edith H. Wilson v. Human Resources 

Jo Ann Kinsey v. NC Memorial Hospital Betty Hutton. Volunteer Svc. 

Amy Clara Williamson v. NC Mem Hosp Betty Hutton, Volunteer Svc. 



CASE 




DATE OF 


PUBLISHED DECISION 


NUMBER 


AL,) 


DECISION 


REGISTER CITATION 


92 CSE 1637 


Nesnow 


05/19/93 




92 CSE 1638 


Reilly 


07/15/93 




92 CSE 1640 


Mann 


07/22/93 




92 CSE 1642 


Morgan 


07/29/93 




92 CSE 1652*' 


Reilly 


03/25/93 




92 CSE 1655 


Reilly 


07/22/93 




92 CSE 1656 


Gray 


07/23/93 




92 CSE 1663 


Reilly 


05/20/93 




92 CSE 1670 


Morrison 


06/25/93 




92 CSE 1671 


Mann 


07/22/93 




92 CSE 1703 


Bee ton 


06/16/93 




92 CSE 1706 


Mann 


06/25/93 




92 CSE 1713 


Mann 


06/08/93 




92 CSE 1714 


West 


07/15/93 




92 CSE 1716 


Gray 


06/17/93 




92 CSE 1718 


Gray 


06/17/93 




92 CSE 1748 


Becton 


08/02/93 




92 CSE 1771 


West 


07/15/93 




92 CSE 1779 


Nesnow 


05/13/93 




93 CSE 0073 


Chess 


08/03/93 




93 CSE 0221 


West 


08/04/93 




93 CSE 0250 


Nesnow 


08/13/93 




93 CSE 0396 


Nesnow 


08/04/93 




93 CSE 0437 


Chess 


08/11/93 




92 DCS 0577 


West 


03/15/93 




92 DCS 1181 


Gray 


05/04/93 


8:5 NCR 441 


92 DCS 1200 


Gray 


03/29/93 




92 DCS 1271 


Reilly 


05/05/93 




92 DCS 1783 


West 


08/04/93 




92 DHR 0658 


Morrison 


04/30/93 


8:4 NCR 392 


92DHR 1101 


Morgan 


07/26/93 




92 DHR 1109** 


Morgan 


06/22/93 


8:8 NCR 687 



92 DHR 1110** Morgan 06/22/93 



92 DHR 1116** Morgan 06/22/93 



92 DHR 1 120 Gray 



06/18/93 



8:8 NCR 687 



8:8 NCR 687 



8:8 NCR 687 



92 DHR 1145 


Becton 


05/13/93 


8:5 NCR 443 


92 DHR 1192 


Nesnow 


04/02/93 


8:3 NCR 313 


92 DHR 1275 


Gray 


03/15/93 




92 DHR 1320 


Morgan 


05/21/93 




92 DHR 1329 


Chess 


05/10/93 




92 DHR 1375 


Chess 


08/02/93 




92 DHR 1604 


Reilly 


05/10/93 




92 DHR 1612 


Chess 


03/08/93 




92 DHR 1613 


Chess 


03/08/93 





8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



1159 



CONTESTED CASE DECISIONS 



AGENCY 



Betty Butler v. Human Resources 

W^ne Sandeis and Brcnda Sanders v. Human Resources 

Samuel Benson v. Office of Admin. Hearings for Medicaid 

Cabarrus Cty Dept. of Social S%cs. v. Human Resources 

Fannie Lewis v. Human Resourc^es 

Human Resources, Div. of Child Development v. Susan Amato 

Katie Kelly v. Human Resources 

INSURANCE 

Carolyn M. Hair v. St Emplcyees Comprehensive Major Medical 
Scotland Memorial Hospital, Mary Home Odom v. Bd. /Trustees// 
St. of N.C. Teachers' &. St. Emp. Comp. Major Medical Plan, and 
David G. Devries, as Exec. Admin, of the N.C. Teachers' & St. Emp. 
Comp. Major Medical Plan 
Phyllis C. Harris v. Teachers' &. St, Emp. Comp. Major Med. Plan 

JUSTICE 

Jermings Michael Bostic v. Sheriffs' Ed. &. Traning Stds. Comra. 
Colin Carlisle Mayers v. Sheriffs' Ed. & Training Stds. Comm. 
Jennings Michael Bostic v. Sheriffs" Ed. & Traning Stds. Comm. 
Michael Charles Kershner v. Criminal Justice Ed & Trainii^ Stds Comm 
George Wilton Hawkins v. Criminal Justice Ed. & Trainir^ Stds. Comm. 
Marilyn Jean Britt v. Cnminal Justice Ed. &. Trainir^ Stds. Comm. 
Tim McCoy Deck v. Criminal Justice Ed. &. Trainir^ Stds. Comm. 
Richard Zander Prink v. Criminal Justice Ed. &. Traning Stds. Comm. 
Sherri Ferguson Revis v. Sheriffs' Ed. & Training Stds. Comm. 
Mark Thomas v. Sheriffs' Ed. &. Training Standards Conmiission 
George Wilton Hawkins v. Sheriffs' Ed. & Training Stds. Comm. 
Lxjnnie Allen Ix)X v. Sheriffs' Ed. &. Training Standards Commission 
Alarm Systems Licensing Bd. v. Eric Hooker 
AlarTTi Systems Licensing Bd. v. Vivian Darlene Gaither 
Llcyd Harrison Bryant Jr. v. Criminal Justice Ed & Training Stds Comm 
William B. Lipscomb v. Pri\'ate Protective Ser\'ices Board 
Pri\ate Protective Svcs. Bd. v. Fred D. Rector 
Pri\Bte Protective Svcs. Bd. v. Alan D. Simpson 

LABOR 

Greensboro Golf Center. Inc. v. Labor 
Ronald Dennis Hunt v. Labor 
Jeffrey M. McKinney v. Labor 

MORTUARY SCIENCE 



CASE 




DATE OF 


NUMBER 


ALJ 


DECISION 


92 DHR 1614 


Chess 


03/09/93 


92 DHR 1699 


ReiUy 


06/07/93 


93 DHR 0010 


Bee ton 


03/11/93 


93 DHR 0373 


Morgan 


07/20/93 


93 DHR 0379 


Gray 


06/28/93 


93 DHR 0418 


Morgan 


08/26/93 


93 DHR 0441 


Chess 


07/26/93 



92 INS 1464 
92 INS 1791 



93 INS 0197 



Chess 
Reilly 



Nesnow 



03/10/93 
08/19/93 



07/29/93 



92 DOJ 0656*" 


West 


06/22/93 


92 DOJ 0761 


Morrison 


05/10/93 


92 DOJ 0829*' 


West 


06/22/93 


92 DOJ 0869 


Morgan 


08/11/93 


92 DOJ 1081*' 


Morgan 


07/09/93 


92 DOJ 1088 


Morrison 


03/16/93 


92 DOJ 1367 


Chess 


04/01/93 


92 DOJ 1465 


Nesnow 


05/28/93 


92 DOJ 1756 


Gray 


03/23/93 


93 DOJ 0151 


West 


04/21/93 


93 DOJ 0156*' 


Morgan 


07/09/93 


93 DOJ 0196 


Morrison 


08/09/93 


93 DOJ 0201 


Becton 


07/12/93 


93 DOJ 0202 


Chess 


05/10/93 


93 DOJ 0377 


Reilly 


08/31/93 


93 DOJ 0458 


Morrison 


06/01/93 


93 DOJ 0479 


Mann 


08/19/93 


93 DOJ 0480 


West 


07/21/93 



92 DOL 0204 


Nesnow 


04/15/93 


92 DOL 1319 


Morgan 


06/17/93 


92 DOL 1333 


Morrison 


06/21/93 



PUBLISHED DECISION 
REGISTER CITATION 



8:7 NCR 632 



I 



i 



Board of Mortuary Science v. Tnai^le Funeral Chapel, Inc. 
PUBLIC INSTRUCTION 

Frances F. Da\is. ferent of Joseph E. Davis v. Public Instruction 
STATE PERSONNEL 



92 EMS 1169 



93 EDC 0628 



Reilly 



Mann 



04/29/93 



07/29/93 



8:4 NCR 396 



Frances K. Pate v. TransporBtion 

Lawrence D. Wilkie, Jerry R. E\ans, Jules R. Hancarl, 

James H. Johnson. James D. Fishel v. Justice 
Lawrence D. Vv'ilkie, Jerry R. Evans. Jules R. Hancart. 

James H. Johnson, James D. Fishel v. Justice 
Laurence D. Wilkie, Jerry R. Evans, Jules R. Hancart, 

James H. Johnson. James D. Fishel v. Justice 
Lawrence D. Wilkie. Jerry R. Evans, Jules R. Hancart, 

James H. Johnson. James D. Fishel v. Justice 
Lawrence D. Wilkie, Jerry R. Evans, Jules R. Hancart, 

James H. Johnson, James D. Fishel v. Justice 
Bemie B. Kellly v. Corrcction 
Brenda G. Mitchell v. Correction 
Adoiph Alexander Justice Jr. v. Motor Vehicles, Transportetion 



88 OSP 0340 


Morrison 


05/03/93 


90 OSP 1064** 


Mann 


05/04/93 


90 OSP 1065*' 


Mann 


05/04/93 


90 OSP 1066** 


Mann 


05/04/93 


90 OSP 1067** 


Mann 


05/04/93 


90 OSP 1068** 


Mann 


05/04/93 


91 OSP 0344 


Morrison 


05/27/93 


91 OSP 0625 


West 


03/08/93 


91 OSP 0860 


Chess 


07/19/93 



8:1 NCR 75 



i 



1160 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



CONTESTED CASE DECISIONS 



AGENCY 



Clayton Brewer v. North Carolina State University 

Sherman Daye v. Transportation 

Donnie M. While v. Correction 

Gregory Samuel Parker v. EnvinDnment, Health, &. Natural Resources 

Renee E. Shepheid v. Winston-Salem State University 

Eva Dockery v. Human Resources 

Lee R Crosby v. Michael Kelly, William Meyer and EHR 

William Marshall Bcyd Jr. v. County Commissioners of Hyde & 

Certain Board of Health Members 
Gregory Samuel Parker v. Environment, Health, & Natural Resources 
Willie Granville Bailey v.Winston-Salem State University 
Julia Spinks v. Envinormient, Health, & Natural Resources 
James B. Price v. Transportation 
I. Caiy Naillir^ v. UNC-CH 
Deborah Barber v. Com^tion 
Laveme B. Hill v. Transportation 
Timmy D. Wilkins v. Transportation 

Sarah W. Britt v. Human Resources, C.A. Dillon School, CPS 
Charles Robinson v. Revenue 

Anna L. Spencer v. Mecklenburg County Area Mental Health 
Herman James Goldstein v. UNC-Chapel Hill et al. 
Glinda C. Smith v. Wildlife Resources Commission 
Cindy G Bartlett v. Correction 

William Kenneth Smith Jr. v. Broughton Hospital (Human Resources) 
Larry O. Nobles v. Human Resources 

Beatrice Wheless v. Lise M. Miller, University Payroll Off., NC St. Univ. 
Sondra Williams v. Winston-Salem State University 
Willie Thomas Hope v. Transportation 
David Scales v. Correction 

Suzanne Ransley Hill v. Environment, Health, &. Nat. Res. 
Herman James Goldstein v. UNC-Chapel Hill el al. 

Beatrice Wheless v. Lise M. Miller, University PaynDll Otf. , NC St. Univ. 
John B. Sauls v. Wake County Health Department 
Gilbert Jaeger v. Wake County Alcoholism Treatment Center 
Joseph Henry Bishop v. Environment, Health, & Natural Res. 
Glenn D. Fuqua v. Rockingham County Board of Social Services 
Willie L. Hudson v. Correction 

Brenda K. Campbell v. Employment Security Commission 
Chnstie L. Guthrie v. Environment, Health, &. Natural Resources 
Sharon Reavis v. Crime Control &. Public Safety 
James B. Price v. Transportation 
Jerry L. Jones v. N.C.S.U. Physical Plant 
Betty Bradsher v. UNC-CH 
Jamal Al Bakkat-Morris v. Glenn Sexton (DSS) 
Brcnda Kay Barnes v. Human Resources 
Larry G. Riddle v. Correction, Division of Prisons 
Stevie E. Dunn v. Polk Youth Center 

Bufoni D. Vieregge Jr v. N.C. State University, University Dinir^ 
Karen Canter v. Appalachian State University 
Terry Steve Brown v. Iredell County Health Department 
Barbara A. Johnson v. Human Resources 
Carrie P. Smith v. County of Stanly 

George W. Allen v. Human Resources, Correction, Agri &. EHNR 
William G Fisher v. St Bd of Ed, Albermarie City Schools &. Bd of Ed 
Grace Jean Washington v. Caswell Center 
Clifton E. Simmons v. Correction 
Willie L. James v. Caswell Center 

Irvir^ S. Rodgers v. C.A. Dillon, Division of Youth Services 
Richard E. Howell v. Correction, Wayne Correctional Center 
Brian Dale Earnhardt v. State Highway Patrol 
RR. "Don" Bowen v. Human Resources 
Michael L. Pegram v. Correction 
Jerry D. Doss Sr. v. Correction 
Debbie Renee Robinson v. Correction 
Michael L. Pegram v. Correction 
Hubert L. Holmes v. Transportation 



CASE 




DATE OF PUBLISHED DECISION 


NUMBER 


AL.I 


DECISION REGISTER CITATION 


91 OSP0941 


West 


04/02/93 8:3 NCR 306 


91 OSP0951 


West 


05/07/93 


91 OSP 1236 


Morgan 


04/05/93 


91 OSP 1344*' 


Chess 


05/20/93 


91 OSP 1391 


Morgan 


04/28/93 


92 OSP 0010 


Chess 


05/03/93 


92 OSP 0056 


Gray 


06/07/93 


92 OSP 0090 


Gray 


08/25/93 


92 OSP 0188** 


Chess 


05/20/93 


92 OSP 0285 


Morrison 


03/10/93 


92 OSP 0313 


Bee ton 


04/12/93 8:4 NCR 382 


92 OSP 0375 


Gray 


04/13/93 


92 OSP 0394 


Bee ton 


04/20/93 


92 OSP 0396 


Chess 


03/04/93 


92 OSP 0431* 


West 


03/08/93 


92 OSP 0432*" 


West 


03/08/93 


92 OSP 0455 


West 


05/26/93 8:6 NCR 484 


92 OSP 0553 


Morgan 


07/21/93 


92 OSP 0584 


Becton 


08/16/93 


92 OSP 0634 


Morrison 


05/04/93 


92 OSP 0653 


Morrison 


03/12/93 


92 OSP 0671 


Morgan 


06/08/93 


92 OSP 0684 


Becton 


05/10/93 


92 OSP 0732 


Mann 


04/23/93 


92 OSP 0744*"' 


Morgan 


07/16/93 


92 OSP 0847 


Morrison 


08/06/93 


92 OSP 0947 


Morgan 


03/23/93 


92 OSP 0989 


Chess 


06/24/93 


92 OSP 0992 


Reilly 


03/18/93 8:2 NCR 224 


92 OSP 1047 


Morrison 


05/04/93 


92 OSP 1 124*^° 


Morgan 


07/16/93 


92 OSP 1142 


Reilly 


03/08/93 8:1 NCR 88 


92 OSP 1204 


Reilly 


05/10/93 


92 OSP 1243 


Reilly 


03/05/93 


92 OSP 1318 


Morrison 


08/03/93 


92 OSP 1468 


Becton 


05/26/93 


92 OSP 1505 


Morrison 


03/17/93 


92 OSP 1555 


Becton 


05/31/93 


92 OSP 1606 


Morrison 


08/19/93 8:12 NCR 1163 


92 OSP 1657 


Mann 


03/19/93 


92 OSP 1661 


Chess 


07/06/93 


92 OSP 1733 


Becton 


03/30/93 


92 OSP 1741 


Becton 


03/24/93 


92 OSP 1768 


Morrison 


03/17/93 


92 OSP 1774 


Gray 


04/26/93 


92 OSP 1789 


Becton 


04/19/93 


92 OSP 1796 


Morrison 


05/27/93 


93 OSP 0079 


Reilly 


06/15/93 


93 OSP 0101 


Morgan 


08/06/93 


93 OSP 0103 


Morrison 


03/17/93 


93 OSP 0109 


Becton 


04/01/93 


93 OSP 0111 


Reilly 


04/16/93 


93 OSP 0134 


Becton 


04/20/93 


93 OSP 0153 


Morgan 


06/03/93 


93 OSP 0159 


Morrison 


04/21/93 


93 OSP 0171 


Morgan 


05/27/93 


93 OSP 0177 


West 


04/21/93 


93 OSP 0245 


Gray 


08/25/93 


93 OSP 0251 


Reilly 


07/27/93 


93 OSP 0253 


Morgan 


08/06/93 


93 OSP 0275** 


Reilly 


06/28/93 


93 OSP 0287 


Gray 


05/17/93 


93 OSP 0383 


Nesnow 


06/07/93 


93 OSP 0472*» 


Reilly 


06/28/93 


93 OSP 0572 


Reilly 


08/17/93 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1161 



CONTESTED CASE DECISIONS 



AGENCY 



STATE TREASURER 

Herman D. Brooks v. Bd of Truslees /Tcacheis' & St Emp Rcl Sys 
Henriette Sandlin v. Teachers' & Stale Emp Comp Major Medical Plan 
Mary Al>ve Carmichael v. Bd/Trustces/Teachcis' Si. St Emp Ret Sys 
W. Rex Perry v. Bd/Trustees/Teacheis' & St Emp Ret Sys 

TRANSPORTATION 



CASE 
NUMBER 



AU 



DATE OF 
DECISION 



PUBLISHED DECISION 
REGISTER CITATION 



4 



9 1 DST 0566 


Gray 


04/13/93 


92 DST 0305 


Morgan 


04/12/93 


92 DST 1506 


Chess 


04/08/93 


93 DST 0133 


West 


08/12/93 



8:11 NCR 992 



■^ates Construction Co. , Inc. v. Transporbtion 
UNIVERSITY OF NORTH CAROLINA HOSPITALS 



92 DOT 1800 Moigan 03/25/93 



Constance V. Graham v. UNC Hospital 
Jacqueline Rorence v. UNC Hospitals 



93 UNC 0269 
93 UNC 0355 



Morgan 
Bee ton 



07/20/93 
06/16/93 



i 



i 



1162 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



CONTESTED CASE DECISIONS 



STATE OF NORTH CAROLINA 
COUNTY OF FORSYTH 



IN THE OFFICE OF 

ADIVUNISTRATTVE HEARINGS 

92 OSP 1606 



SHARON REAMS, 
Petitioner, 



V. 



N.C DEPARTMENT OF CRIME CONTROL AND 
PUBLIC SAFETY, DIVISION OF VICTIM AND 
JUSTICE SERVICES, 
Respondent. 



RECOMMENDED DECISION 



The appeal of Sharon Reavis, a former employee of the North Carolina Department of Crime Control 
and Public Safety, Division of Victim and Justice Services, was heard by Fred G. Morrison Jr., Senior 
Administrative Law Judge, Office of Administrative Hearings, on July 14 and 15, 1993, in Raleigh, North 
Carolina. Following the hearing, the parties filed proposed decisions. 



APPEARANCES 

Marvin Schiller 
Attorney at Law 
Raleigh, North Carolina 

Linda M. Fox 
Assistant Attorney General 
N.C. Department of Justice 
Raleigh, North Carolina 

ISSUE 



FOR THE PETITIONER: 



FOR THE RESPONDENT: 



Whether the Respondent had just cause (procedurally and substantively) to terminate Petitioner's 
employment. 

OPINION OF THE ADMINISTRATIVE LAW JUDGE 

FINDINGS OF FACT 

1. Petitioner Sharon Reavis was a program manager responsible for the Community Service Work 
Program in Forsyth County. Her duties included maintaining her own community service clients and 
supervising four Community Service Coordinators. She had been continually employed by the 
Respondent from October 1, 1984, until she was dismissed on September 30, 1992. She was in pay 
grade 66 when terminated. 

2. In September of 1990, Larry F. Habegger pled guilty in Forsyth County Superior Court to five counts 
of embezzling trust funds. Judge Coy E. Brewer, Jr. sentenced him to three years in prison, but 
suspended it and placed him on supervised probation for five years. Special conditions of Habegger's 
probation were that he serve 5 consecutive days in the Davie County jail once each year for 5 years; 
that he make restitution in the amount of $48,253.04 to the Young Trust of Thomasville, NC; and, 
that he complete 600 hours of community or reparation service during the period of probation, as 



8:12 



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September 15, 1993 1163 



CONTESTED CASE DECISIONS 



directed by the community service coordinator. The judge intended that Habegger complete at least 
120 hours of community service during each of the five years of his probationary sentence. He did 
not specify the county where Habegger was to perform community service. 

3. Prior to his trial, Habegger had been referred for community-based punishment and therefore 
community service because he had no prior record and appeared to be an excellent risk. On January 
22, 1990, Petitioner by memo told the referral source that a tentative placement site had been located 
for Habegger. 

4. TTie Petitioner and most of the members of her staff knew Mr. Habeggar because he had either 
performed legal services for them or because he was a local attorney. The Petitioner knew Mr. 
Habegger for both reasons. Mr. Habegger was competent and well-liked. 

5. It was a common practice in Area D, which included Forsyth County and was supervised by Becky 
MuUins, to transfer cases to the county where the probation officer supervising a defendant was 
located. In Mr. Habegger's case, that county was Davie. The Petitioner chose not to transfer Mr. 
Habegger's case, but retained it in Forsyth. Judicial Notice is taken of the fact that Forsyth and 
Davie counties adjoin and Advance is only a few miles from Winston-Salem. 

6. Larry Habegger lived in Advance, Davie County, NC, where he was supervised by a local probation 
officer. He had graduated from Wake Forest University Law School and practiced law in Winston- 
Salem, Forsyth County, NC, prior to his sentence. 

7. Habegger went to Petitioner's office for an official interview on October 23, 1990. Ms. Reavis 
assigned his case to coordinator Jean Guiterrez because the latter was new and had no prior 
relationship with Habegger. Ms. Guiterrez had been with the office for nine months. The other 
coordinators had five and nine years experience. Mr. Habegger's case was the highest profile case 
Ms. Guiterrez was assigned in 1990. 

8. On March 10, 1992, the Petitioner, in a random case review, selected Mr. Habegger's case file which 
was maintained by Ms. Guiterrez. Mr. Habegger was to have completed 120 hours of community 
service in each year and by 3/10/92, should have completed more than 120 hours. The file reviewed 
by the Petitioner indicated Mr. Habegger was told in October 1990 to report to the Forsyth County 
Clerk's Office and perform community service, and he failed to show up. Mr. Habegger was not 
reported for noncompliance nor did the file contain any explanation for his failure to appear. From 
December 1990 until March 1991, there was no direct contact between Mr. Habegger and Ms. 
Guiterrez. 

9. According to the file, in March 1991, Mr. Habegger was reassigned to the Salvation Army Boys Club 
by Ms. Guiterrez to do his community service. He did not report there. Mr. Habegger was not 
reported for noncompliance nor was there any explanation for his failure to appear. 

10. In October 1991, Mr. Habegger submitted hours he claimed to have performed in Davie County with 
a little league ball team and at Brenner Children's Hospital in Forsyth County raising funds and 
organizing a golf tournament. He had placed himself with both agencies in violation of Respondent's 
policy 

1 1 . Tliese hours were not approved by Petitioner as legitimate community service work because no proper 
assignment had been made prior to the service. Also, the Davie team was never an approved agency 
and Brenner's not until mid- 1991 after most of Habegger's claimed hours. Mr. Habegger was 
approved for service with Brenner when it executed and returned an agreement on July 15, 1991. 
In July of 1992, Ms. Guiterrez incorrectly advised Habegger's attorney that his client had complied 
with community service requirements through work at Brenner Children's Hospital. 

12. Pursuant to V&J Policy, a coordinator must first find an approved agency and then assign a client to 



1164 8:12 NORTH CAROLINA REGISTER September 15, 1993 



CONTESTED CASE DECISIONS 



that agency. Every thirty days, the coordinator is to monitor the progress of a client. The file 
reviewed by the Petitioner showed Ms. Guiterrez had talked to Mr. Habegger five times in 17 
months. She had made several other attempts, as had he, without connecting. 

13. If a client fails to appear or does not perform his assigned community service hours without 
justification, he is to be reported back to court for failure to comply with conditions of probation 
either through the probation officer or by the coordinator when it is unsupervised probation. 

14. The Petitioner, after reviewing all the improprieties in Mr. Habegger's file on March 10, 1992, 
concluded that he had approximately 17 hours of valid community service of the more than 120 hours 
needed. 

15. The Petitioner did not require that Mr. Habegger be reported to his probation officer for being in 
noncompliance on March 10, 1992, when she became aware of it; instead, the Petitioner instructed 
Ms. Guiterrez to transfer the case to Davie County. 

16. The case was not transferred on March 10, 1992; had not been transferred when the Petitioner went 
out on sick leave on March 23, 1992; and, still was not transferred when she returned from leave on 
April 27, 1992. 

17. In September 1992, Mr. James Coman of the Attorney General's Office called the Director of Victim 
and Justice Services, Art Zeldman, inquiring about the number of hours of community service 
performed by Mr. Habegger. Efforts were being made to defeat an attempt by Habegger's attorney 
to get his client's probation terminated. Coman had prosecuted the cases in Superior Court and was 
concerned that the community service and jail time were not being completed as ordered. 

18. An investigation was conducted by Mr. Zeidman and his staff, and the Petitioner and Ms. Guiterrez 
were questioned about the case in September. As of September of 1992. the case had not been 
transferred to Davie County. Ms. Guiterrez testified that Habegger's attorney and probation officer 
asked her to delay any transfer until a decision was reached on the request for termination of 
probation. 

19. The Petitioner first told Mr. Zeidman her last involvement with the case was when she told Ms. 
Guiterrez to clean up the file and transfer the case to Davie County on March 10, 1992. 

20. Ms. Guiterrez, on the other hand, told Mr. Zeidman the Petitioner was aware of the lack of hours 
performed by Mr. Habegger and when the Petitioner returned from sick leave, was aware of the delay 
in transferring the case. 

When mfbrmed of this contradiction. Petitioner told Zeidman that perhaps she did mention the 
transfer to Guiterrez following her return to work. 

21. On September 28, 1992, Becky Mullins, Area Manager, conducted a predismissal conference with 
the Petitioner advising her that Mr. Zeidman was considering terminating her on September 30, 1992. 

22. During the conference, the Petitioner was advised her action was considered personal misconduct. 
The misconduct was stated to be showing favoritism to Habegger and not having him reported to his 
probation officer in March of 1992 for failure to do community service from October of 1990 through 
March of 1992 as ordered by the court. 

23. The Petitioner was also advised that she was believed to have been untruthful to Mr. Zeidman when 
he first inquired about her knowledge of and involvement with the Habegger case following her return 
from surgery. 

24. The Petitioner was given the opportunity to present additional information to Mr. Zeidman before the 
final decision was made, but did not do so. 



8:12 NORTH CAROLINA REGISTER September 15, 1993 1165 



CONTESTED CASE DECISIONS 



25. Mr. Zeidman discharged Petitioner from employment by letter to her dated September 30, 1992. The 
termination letter states, in essence, that the "specific incidents" of alleged personal misconduct are: 

1. That in October 1990, you showed fevoritism toward a criminal defendant, Larry Habegger, 
by failing to transfer his case to Davie County, and in March of 1992, by failing to require 
Jean Guiterrez to close his case, and instead asking her to transfer it, in violation of policy. 

2. That on September 23, 1992, when asked about the Habegger case, you changed your story 
as to your knowledge and involvement. 

3. That you knew or should have known that Habegger was seeking credit for hours not worked 
or not approved, and failed to take immediate action. 

26. Mr. Zeidman also dismissed Jean Guiterrez for her conduct in this matter. Following her appeal of 
this termination, Ms. Guiterrez reached a settlement with the agency and has been reinstated. Also, 
Zeidman informed Coman of these disciplinary actions. 

27. On December 7, 1992, Mr. Habegger appeared in court before Judge Coy E. Brewer, Jr. to request 
that his probation be terminated. Through his attorney , Mr. Habegger claimed to have paid the 
$48,253.04 in restitution and completed the required hours of community service due to that date. 
TTie Attorney General's Office did not oppose termination on the grounds of failure to pay restitution 
or perform required community service, but objected because Habegger had only completed five days 
of the 25 days in jail. James Coman argued that justice required that Habegger serve 20 more days 
in jail before termination. Judge Brewer ordered that Habegger's probation be terminated as of 
January 31, 1993, provided that by that date he had served an additional ten days \n jail. 

Based on the foregoing Findings of Fact, the Administrative Law Judge makes the following: 

CONCLUSIONS 

1. Sharon Reavis, Petitioner, was a permanent State employee at the time of her dismissal. Because she 
has alleged that Respondent lacked just cause for her dismissal, the Office of Administrative Hearings 
has jurisdiction to hear her appeal and issue a recommendation to the State Personnel Commission 
which shall make the final decision in this matter. G.S. 126-35, 126-37, 126-39, 150B-23 and 150B- 
36. 

2. G.S. 126-35 provides, in part, "that no permanent employee subject to the State Personnel Act shall 
be dismissed, except for just cause." Where just cause is an issue. Respondent bears the ultimate 
burden of persuasion. A just cause issue carries both substantive and procedural questions. Causes 
for dismissal fall into two categories: (1) causes relating to performance of duties; and (2) causes 
relating to personal conduct detrimental to State services -- no prior warnings are required under (2). 

3. In Jones y^ Department of Human Resources , 300 NC 690, 691 (1980), the Supreme Court of North 
Carolina held that "prior to dismissal for causes relating to performance of duties, a permanent State 
employee is entitled to three separate warnings that his performance is unsatisfactory. He must 
receive: (1) an oral warning explaining how he is not meeting the job's requirements; (2) a second 
oral warning outlining his unsatisfactory performance with a follow-up letter reviewing the points 
covered by the oral warning; (3) a final written warning setting forth in numerical order the specific 
acts or omissions that are the reasons for the disciplinary action." 

4. Respondent has not met its burden of showing just cause for terminating Petitioner's employment. 
While it is concluded that Ms. Reavis failed to exert effective control over and properly manage the 
Habegger case, such behavior falls in the area of improper job performance rather than personal 
conduct. Since there was no evidence that she had received prior warnings, dismissal was not in 
order. A warning was appropriate. 



1166 8:12 NORTH CAROLINA REGISTER September 15, 1993 



CONTESTED CASE DECISIONS 



As to charges of favoritism, Petitioner did no fevors in approving a convicted attorney for community 
service work in the Clerk of Court's Office in the county of his conviction. It would have been 
difficult for him to look those people in the eye each day, which could be why he failed to report. 
Furthermore, the Salvation Army Boys Club assignment was appropriate for an attorney who had 
embezzled funds from clients who trusted him. One goal of community service is hopefully a change 
in values on the part of offenders. The Salvation Army certainly offers that possibility. 

This was a case of supervised probation with three special conditions. Ms. Reavis did not abuse her 
discretion by not seeking immediate revocation only 17 months into a 60 month probationary period, 
which the sentencing judge ordered terminated at the completion of 28 months on January 31, 1993. 

Respondent's second reason in the letter of dismissal was not specific enough to satisfy statutory 
requirements, nor did the evidence show a change significant enough to warrant dismissal. 

Based on the foregoing Findings of Fact and Conclusions, the Administrative Law Judge makes the 
following: 

RECOMMENfPED DECISION 

That the Petitioner be reinstated with full benefits, including back pay and attorney's fees, with an 
appropriate warning being given her for inadequate job performance. 

ORDER 

It is hereby ordered that the agency serve a copy of the final decision on the Office of Administrative 
Hearings, P.O. Drawer 27447, Raleigh, N.C. 2761 1-7447, in accordance with North Carolina General Statute 
150B-36(b). 

NOTICE 

The agency making the final decision in this contested case is required to give each party an 
opportunity to file exceptions to this recommended decision and to present written arguments to those in the 
agency who will make the final decision. G.S. 150B-36(a). 

The agency is required by G.S. 150B-36(b) to serve a copy of the final decision on all parties and to 
furnish a copy to the parties' attorney of record and to jhe Office of Administrative Hearings. 

The agency that will make the final decision in this contested case is the State Personnel Commission. 

This the 19th day of August, 1993. 



Fred G. Morrison Jr. 

Senior Administrative Law Judge 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1167 



CONTESTED CASE DECISIONS 



STATE OF NORTH CAROLINA 



COUNTY OF IREDELL 



IN THE OFFICE OF 

ADMEVISTRATTVE HEARINGS 

93 HRC 0167 



HUMAN RELATIONS COMMISSION 
on behalf of MARSHA CRISCO, 
Petitioner. 



V. 



HAYDEN MORRISON, 
Respondent. 



PROPOSAL FOR DECISION 



This matter came on for hearing before the undersigned administrative law judge on July 7, 1993, 
in Statesville. 

Mr. Daniel D. Addison represented the petitioner. Mr. Philip M. Van Hoy represented the 
respondent. The petitioner presented three witnesses and introduced Exhibits #1-3. The respondent presented 
seven witnesses and introduced Exhibits #1, 3, 5. 6, and 8. Proposed Findings of Fact were filed on August 
4 and 17, 1993. 

ISSUE 

Did the respondent violate G.S. 41A-4(a)(l) and (6) by refusing to engage in a real estate transaction 
and by making a statement indicating an intent to discriminate against Marsha Crisco because of familial 
status? 

STIPULATIONS 



2. 



78.7% of the lots at Leisurewood Mobile Home Estates were occupied in March - April, 1991, by 
at least one person 55 years of age or older. 

The residents of Leisurewood adhered to the rules and regulations of the mobile home park and the 
respondent enforced the rules and regulations, except for #22 which provided that "No one under 40 
years of age will be excepted (sic) in the park." 



FINDINGS OF FACT 



2. 



In March - April, 1991, Marsha Crisco and her son, Scott, who was one year old, were searching 
for a place to live. Ms. Crisco was recently separated from her husband. She and her husband were 
selling their house in Charlotte. Ms. Crisco hoped to move near Moorseville where her parents lived 
so that they might assist her in caring for her handicapped son. 

The respondent is the owner and manager of Leisurewood Mobile Home Estates (hereinafter 
"Leisurewood") in Iredell County. Leisurewood has no facilities and services specially designed for 
older persons. There was no evidence that Leisurewood provided housing under any State or federal 
program for elderly persons. Leisurewood was not occupied solely by persons 62 years of age or 
older. 



Ms. Crisco's father knew the respondent and asked him if his daughter could rent a lot in 
Leisurewood. The respondent stated that he did not rent to adults with children. Her father had given 



1168 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



CONTESTED CASE DECISIONS 



the respondent a news article stating that discrimination in housing against femilies with children was 
prohibited. 

4. Her fether told Ms. Crisco about his conversation with the respondent. Nevertheless, Ms. Crisco and 
her mother decided to stop at Leisurewood and speak to the respondent. Ms. Crisco asked the 
respondent if she could rent a lot at Leisurewood. The respondent said no and made a statement that 
he did not rent to individuals who were under 40 years of age, single, or had children. Ms. Crisco 
felt humiliated and embarrassed at being denied a place to live. Several tenants at Leisurewood were 
under 40 years of age. 

5. Although Ms. Crisco had hoped, with her father's assistance, to purchase a mobile home in order to 
have more space than an apartment and to make an investment, she decided to rent an apartment 
because no other mobile home park was as well kept as Leisurewood. She spent $30 and, on and after 
February 1, 1993, $35 per month for renting storage space for furniture that could not fit into her 
apartment. There was no evidence whether the apartment rent plus the storage rent was greater than 
what she would have had to pay for the lot rent and monthly payments on the mobile home. 

6. At the hearing, the respondent contended that the mobile home park was full (either mobile homes 
were on the lots or individuals had reserved the lots), but he did not offer, in March - April, 1991, 
to place Ms. Crisco's name on his waiting list. It was the respondent's practice to offer individuals 
the opportunity to place their names on the waiting list. Furthermore, contrary to the respondent's 
contention, the mobile home park had three vacancies during March - April, 1991, when Ms. Crisco 
asked to rent a lot. The records of Duke Power Company showed that on Lot #3, service was 
disconnected on 10/24/90 and reconnected on 9/25/91; on Lot #25, service was disconnected on 
2/26/91 and reconnected on 6/14/91; and on Lot #35, service was disconnected on 8/14/90 and 
reconnected on 5/13/91. TTie respondent's rental and deposit receipt book (more trustworthy than a 
hand-made rent payment chart) may have indicated that there were deposits on the lots, but the 
respondent failed to produce the book at the hearing. (TTie respondent had answered an interrogatory 
on June 16, 1993, that he would produce the book. T p 186) The respondent's contention that he took 
the rental and deposit receipt book to a copier less than three weeks before the hearing and 
subsequently lost the book and the copy lacks any credibility. ("I got it back but its been lost or 
misplaced since." Morrison, T p 188) Furthermore, this complete lack of credibility supports a 
finding that there were no deposits on the three lots. Therefore, the undersigned finds that three lots 
in Leisurewood were vacant with no deposits on them in March - April, 1991, when Ms. Crisco 
asked to rent a lot. 

7. Animus against Ms. Crisco's son living with her was the motivation for the respondent's failure to 
rent a lot to Ms. Crisco in Leisurewood. 

CONCLUSIONS OF LAW 

1. The respondent intentionally violated G.S. 41A-4(a)(l) in March - April, 1991, by refusing to rent 
a mobile home lot to Ms. Crisco because of familial status. 

2. The respondent intentionally violated G.S. 41A-4(a)(6) in March - April. 1991, by making verbal and 
written statements indicating his intent to discriminate in a real estate transaction because of Ms. 
Crisco's familial status. 

3. The exemption in G.S. 41A-6(e) with respect to housing for older persons is inapplicable to 
Leisurewood. 

4. Ms. Crisco, pursuant to G.S. 41A-7, is entitled to compensatory damages of two thousand dollars 
($2,000.00) from the respondent for her humiliation and embarrassment as a result of the respondent's 
feilure to rent a mobile home lot to her because of familial status. 



8:12 NORTH CAROLINA REGISTER September 15, 1993 1169 



CONTESTED CASE DECISIONS 



5. The petitioner, pursuant to G.S. 41 A-7, is authorized to assess a civil penalty against the respondent. 

6. The petitioner, pursuant to G.S. 41 A-7, is authorized to enjoin future violations. 

PROPOSAL FOR DECISION 

It is proposed that (i) the respondent compensate Ms. Crisco in the amount of two thousand dollars 
($2,000.00), (ii) the respondent pay a civil penalty of two thousand dollars ($2,000.00), and (iii) the 
respondent be ordered to cease his discriminatory policies and practices. 

NOTICE 

The final decision in this contested case shall be made by the Human Relations Commission. Each 
party has the right to file exceptions and proposed findings of fact and to present oral and written arguments 
on the decision to this agency. 



i 



This the 18th day of August, 1993. 



Robert Roosevelt Reilly, Jr. 
Administrative Law Judge 



i 



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1170 8:12 NORTH CAROLINA REGISTER September 15, 1993 



CONTESTED CASE DECISIONS 



STATE OF NORTH CAROLINA 
COUNTY OF WASHINGTON 



IN THE OFFICE OF 

ADMINISTRATrVE HEARINGS 

93 GPS 0205 



NORMA JEAN PURKETT 
Petitioner, 



V. 



CRIME VICTIMS COMPENSATION COMMISSION, 
Respondent. 



RECOMMENDED DECISION 



This contested case was heard on July 19, 1993 in Williamston, North Carolina, by Administrative 
Law Judge Thomas R. West. 

APPEARANCES 

Petitioner, Norma Jean Purkett, appeared on her own behalf. 

Respondent was represented by Assistant Attorney General, Joseph P. Dugdale. 

ISSUE 

Did the North Carolina Crime Victims Compensation Commission err in one of the five ways 
described in G.S. 150B-23 when it denied Petitioner's claim for victim's compensation for expenses incurred 
as the result of the criminal homicide of Petitioner's father? 

BURDEN OF PROOF 

The burden is on Petitioner to prove by the greater weight of the substantial evidence that Respondent 
erred by denying compensation. 

OmCIAL NOTICE 

Official notice is taken of Chapter 15B of the General Statutes of North Carolina. G.S. 15B-ll(b) 
is the basis of the action taken by Respondent Commission. 

WITNESSES 

The following persons testified on behalf of Respondent: 

Joyce Hyman 

Emanuel Lee Hyman 

Eric A. Hooks - SBI Special Agent 

The following persons testified on behalf of Petitioner: 

Sgt. Leo C. Ussery - Plymouth, N.C. Police Department 
Sheila Kendall 
Rebecca Barrett 
Robin L. McNair 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1171 



CONTESTED CASE DECISIONS 



STATEMENT OF THE CASE 

On the night of September 3, 1991, Robert McNair walked out of the church he served as pastor. 
Emanuel Lee Hyman struck and killed Rev. McNair. Hyman was charged with McNair's murder. In March 
1992, Hyman was tried for murder, convicted of voluntary manslaughter, and sentenced to serve 120 days 
in jail. 

The McNair family incurred medical expenses of $7,000.00 (Seven Thousand Dollars) and funeral 
expenses of over $2,000.00 (Two Thousand Dollars) as the result of the criminal homicide of Rev. McNair. 

Norma J. Purkett, Rev. McNair's daughter, filed a claim with the Crime Victims Compensation 
Commission for reimbursement of the expenses. 

On November 18, 1992, the Director of the Commission recommended to the Commission that the 
claim be denied. The Director found that "-■ t-| he offender discovered the victim with the offender's wife 
at the location and became angered." From this finding, the Director concluded that McNair's misconduct 
contributed to his death, so that pursuant to G.S. 15B-Il(b), the claim for victim's compensation must be 
denied. 

The Commission considered the Director's recommendation, and on January 8, 1993, ordered that 
Purkett's claim be denied. Purkett filed the petition commencing this contested case and challenging the 
Commission's decision on February 22, 1993. 

FINDINGS OF FACT 

1 . Norma Jean Purkett is the daughter of Robert L. McNair, Sr. Purkett qualifies as a "claimant" under 
the North Carolina Crime Victims Compensation Act (Chapter 15B of the North Carolina General 
Statutes). Charges for medical service rendered to Robert L. McNair at the time of his death and his 
funeral expenses, up to $2,000.(X) (Two Thousand Dollars), are "allowable expenses" payable to 
Purkett from the Crime Victims Compensation Fund. 

2. Claims for compensation exceeding $5,000.00 (Five Thousand Dollars) are decided by the Crime 
Victims Compensation Commission on a review of written evidence submitted to the Commission by 
the Director of the Commission. Purkett's claim exceeded $5,000 (Five Thousand Dollars) and was 
denied by the Commission. 

3. The Commission denied F\irkett's claim pursuant to G.S. 15B-ll(b). The Commission took the 
position in denying Purkett's claim that because Rev. McNair was "... with the offender's wife ... 
" at the time he was killed, his misconduct contributed to his death so that the claim should be denied. 
The Commission's meaning is not apparent unless one uses his imagination and presupposes that it 
is not misconduct to be in the presence of another man's wife. 

4. The Plymouth police and the SBI investigated Rev. McNair's homicide. In addition, the criminal trial 
and conviction of Emanuel Hyman preceded the Commission's determination. The Commission 
reviewed information from all of these sources in making its determination that Purkett's claim should 
be denied. 

5. Robert L. McNair, Sr. was the pastor of a church in Plymouth. McNair was at least 50 years of age 
at the time of his death and had been a widower for approximately ten (10) years. 

6. Emanuel Lee Hyman and Joyce Hyman have been married for approximately 19 (nineteen) years. 
The two have three (3) children. The Hymans joined Rev. McNair's church in 1978, but left the 
church in the early 1980s because Rev. McNair and Joyce Hyman were having an affair. The 
Hymans separated for approximately one (1) year at the time they left Rev. McNair's church. 



1172 8:12 NORTH CAROLINA REGISTER September 15, 1993 



CONTESTED CASE DECISIONS 



7. Emanuel Lee Hyman became the pastor of Temple Christian Church. 

8. Joyce Hyman resumed attending Rev. McNair's church one (1) year after she and Emanuel had left 
the church. Rev. Hyman accepted his wife's return to Rev. McNair's church but did not bless it. 
Joyce Hyman became the Associate Minister of McNair's church. 

9. Rebecca Barrett has known Robert McNair ever since she was fifteen (15) years old. Barrett and 
McNair were engaged to be married in their youth. McNair is the father of Barrett's daughter Sheila 
Kendall. Barrett did not marry McNair and moved to New York City. Barrett and McNair both 
subsequently married other people and the two families remained close. Barrett's family visited 
Plymouth once or twice a year for a week. Sheila Kendall spent most of the summers during her 
youth in Plymouth in Rev. McNair's home. 

Approximately ten (10) years ago. Rev. McNair's wife died. Approximately five (5) to six (6) years 
ago, Barrett's husband died. Rev. McNair asked Barrett to marry him and confessed he was having 
an affair with Joyce Hyman, but wanted it to be over. 

Barrett and Rev. McNair became engaged, but through the intervention of Barrett's minister, she did 
not marry McNair. 

11. Sometime during 1989 or 1990, Rev. McNair told his daughter. Sheila Kendall, of his affair with 
Joyce Hyman. Kendall understood that the affair was ending then, and understood that her father had 
approached Emanuel Hyman several times to make peace. 

12. In September 1991. Rev. McNair told Rebecca Barrett that he wanted to resume their engagement 
and get married. Rev. McNair admitted his affair with Joyce Hyman. McNair was depressed about 
the relationship. Many people had left Rev. McNair's church by this time because of the affair. 

13. Robin McNair is Rev. McNair's youngest daughter. Her father sought her forgiveness in 1990 for 
his having an affair with Joyce Hyman. Robin McNair believed the affair was over in 1991 when 
Rev. McNair resumed his engagement with Rebecca Barrett. 

14. Joyce Hyman had an affair with Rev. McNair in the early 1980's and resumed the affair after she 
resumed living with her husband and returned to Rev. McNair's church. Joyce Hyman and her 
husband, Emanuel, often had words about the relationship. Rev. Hyman had words with Rev. 
McNair about the affair on occasion. At times the confrontations became heated. 

15. At some date right before September 3. 1991. Joyce Hyman told Emanuel Hyman that her affair with 
McNair was over. 

16. On the night of September 3. 1991 (Tuesday), Joyce Hyman went to a prayer service at Rev. 
McNair's church. She left the church after the service ended, but then returned. Hyman was in a 
room with McNair with all the lights out. All the doors to the church were locked. Joyce Hyman 
and Rev. McNair talked about ending their affair and Joyce Hyman kissed Rev. McNair. Joyce 
Hyman testified that nothing unseemly happened that night between her and Rev. McNair, but 
testified that she couldn't say something wouldn't have happened if her husband hadn't come to the 
church. 

17. Rev. Hyman knew his wife been having an affair with Rev. McNair for several years and believed 
she was having an affair with McNair in September 1991. 

Emanuel Hyman testified that he came to Rev. McNair's church on the night of September 1991 
because he had a doctor's appointment the next day and needed to get some X-Rays out of Joyce's 
car. 



8:12 NORTH CAROLINA REGISTER September 15, 1993 1173 



CONTESTED CASE DECISIONS 



19. Emanuel Hyman testified at the hearing as follows: 

When Rev. Hyman got to the church, all the lights were off. All the doors of the church were 
locked. Rev. Hyman knocked at the front door and at a side door No one answered. Rev. McNair 
came out of the church and came at Rev. Hyman with his fists raised. Hyman backed up, picked up 
a stick and started swinging it. Rev. Hyman knocked Rev. McNair down, threw the stick away and 
ran away. 

20. The autopsy performed on Rev. McNair showed that his skull was indented on the left side, his left 
collarbone was broken, two ribs were broken on his left side, and one of his arms was bruised. 

21. Rev. Hyman testified on cross-examination by Purkett that he did not go to the church with the idea 
of catching his wife with Rev. McNair. Hyman observed that if he had wanted to catch his wife and 
McNair in an affair, he could have done so many times. Purkett questioned the credibility of Rev. 
Hyman's testimony that McNair charged him. Hyman responded that you never know what a man 
is thinking that is doing something wrong. 

22. On September 4, Hyman turned himself in to the Plymouth police and confessed to killing Rev. 
McNair. 

23. The SBI investigated the homicide at the request of the Plymouth Police. Special Agent Eric A. 
Hooks interviewed Emanuel Hyman several times. Hyman's testimony at this contested case hearing 
is consistent with the stor>' he consistently told to Hooks of the events which led to the death of Rev. 
McNair. Hyman's testimony at this contested case hearing is consistent with his testimony at his 
criminal trial. 

24. Sgt. Leo C. Ussery also interviewed Emanuel Hyman after Hyman turned himself in to the police. 
The statement Hyman gave to Ussery on September 5, 1991 is consistent with Hyman's testimony 
at this contested case. 

25. Emanuel Hyman was charged and tried in Superior Court for the murder of Robert L. McNair, Sr. 
Hyman was found not guilty of murder Hyman was found guilty of voluntary manslaughter and 
sentenced to a jail term of 120 (One Hundred Twenty) days. Hyman has served that term. 

Based on the foregoing, the undersigned makes the following: 

CONCLUSIONS OF LAW 

1. The Commissions written denial of Purkett "s claim for compensation from the Crime Victims 
Compensation Fund is vague and ambiguous. 

2. McNair placed himself in a position on the night of his homicide in which Hyman could reasonably 
conclude that his wife and McNair were engaged in an extra-marital affair. 

3. Emanuel Hyman's acquittal of murder and conviction of voluntary' manslaughter by a jury negates 
the element of malice in Hyman's killing of McNair. 

4. Emanuel Hyman killed Rev. McNair because either he acted in self defense to McNair's attack and 
used excessive force or he acted in the heat of passion and killed McNair because of McNair's long 
term affair with Joyce Hyman. 

5. . Either scenario results in a conclusion that Rev. McNair was engaged in misconduct, and a conclusion 

that the misconduct contributed to his death. 

6. The Commission's denial of compensation benefits to Purkett, although vague and ambiguous, is not 



1174 8:12 NORTH CAROLINA REGISTER September 15, 1993 



CONTESTED CASE DECISIONS 



erroneous in one of the ways described in G.S. 150B-23. 

Based on the foregoing, the undersigned makes the following: 

RECOMMENDED DECISION 

The request for relief in the petition for contested case hearing should be DENIED. 

ORDER 

It is hereby ordered that the agency serve a copy of the final decision on the Office of Administrative 
Hearings, P.O. Drawer 27447, Raleigh, N.C. 2761 1-7447, in accordance with North Carolina General Statute 
150B-36(b). 

NOTICE 

The agency making the final decision in this contested case is required to give each party an 
opportunity to file exceptions to this recommended decision and to present written arguments to those in the 
agency who will make the final decision. G.S. 150B-36(a). 

The agency is required by G.S. 150B-36(b) to serve a copy of the final decision on all parties and to 
furnish a copy to the parties' attorney of record and to the Office of Administrative Hearings. 

The agency that will make the final decision in this contested case is the Crime Victims Compensation 
Commission. 



This the 27th day of August, 1993. 



Thomas R. West 
Administrative Law Judge 



8:12 NORTH CAROLINA REGISTER September 15, 1993 1175 



CONTESTED CASE DECISIONS 



STATE OF NORTH CAROLINA 



COUNTY OF HALIFAX 



IN THE OmCE OF 

ADMINISTRATIVE HEARINGS 

93 EHR 0276 



FRED M. GROOMS 
Petitioner, 



N. C. DEPARTMENT OF ENVIRONMENT, 
HEALTH. AND NATURAL RESOURCES 
Respondent. 



RECOMMENDED DECISION 



This contested case was heard on July 19, 1993, in Halifax, North Carolina by Administrative Law 
Judge Thomas R. West. 

APPEARANCES 

Petitioner appeared gro se. 

Respondent was represented by Assistant Attorney General, Marjorie Canaday. 

PREHEARING ORDER 

Prior to receiving any evidence, the Administrative Law Judge, in response to motion by the Attorney 
General, substituted the Department of Environment, Health and Natural Resources as the Respondent in this 
case, and dismissed the contested case against Halifax County and the two individuals named in the Petition. 
Although Mr. Grooms" dealings have been with the Halifax County Health Department, the Health 
Department and its employees have acted as agents of the state Department when applying and enforcing the 
laws and rules governing sanitary sewage collection, treatment, and disposal. A cause of action cannot be 
stated against the Halifax County Health Department or its individual employees. 

WITNESSES 

The following testified on behalf of Respondent: 

Moulton Bailey - Environmental Health Specialist with the Halifax County Health Department. 

Jeff N. Dillard - Environmental Health Supervisor with the Halifax County Health Department 
(Specialist at times relevant to this case). 

Rebecca W. Edwards - Environmental Health Supervisor with the Halifax County Health Department 
(at those times relevant to this case). 

The following testified on behalf of Petitioner: 

Mrs. Fred Grooms - wife of the Petitioner. 
Fred Grooms - Petitioner. 



1176 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



CONTESTED CASE DECISIONS 



EXHTOITS 

Listing of exhibits was omitted from this publication. If you would like a copy of the listing of 
exhibits, please contact the Office of Administrative Hearings. 

ISSUES 

The parties stipulated at the hearing that the issue to be resolved in this contested case is as follows: 

1. Whether the Petitioner erred in installing a bed type wastewater field on his property without 
first obtaining an improvement permit from the Halifax County Health Department. 

Respondent sought a stipulation that another issue was to be resolved. The issue is as 
follows: 

2. Whether the improvement permit issued to the Petitioner by the Halifax County Health 
Department on December 11, 1992 is correct as to the additional amount of drainfield 
required to be installed. 

Petitioner did not stipulate that Issue #2 was appropriate to be resolved. Over Mr. Grooms' 
objection, the Administrative Law Judge ruled that Issue #2 would be decided. 

BURDEN OF PROOF 

The burden is on Respondent to show by the greater weight of the substantial evidence that it should 
prevail on both issues. 

OFFICIAL NOTICE 

Oflicial notice is taken of the following: 

1. Article 1 1, Chapter 130A of the General Statutes of North Carolina. 

2. 15A NCAC 18A .1900 et. sea. 

STIPULATED FACTS 
The parties stipulated to the following undisputed facts: 

1. There is a two bedroom residence existing on the Petitioner's property which property is the 
subject of this contested case. 

2. On or about October 14, 1992, the Petitioner caused to be installed on his property a bed 
type wastewater field which measures approximately 8 feet by 50 feet. 

3. The Petitioner did not obtain an improvement permit from the Halifax County Health 
Department prior to installing the bed type field. 

Based on the substantial evidence admitted, the undersigned finds the following to be the facts: 

FINDINGS OF FACT 

1. On October 14, 1992, a resident of Halifax County complained to the Halifax County Health 

Department that Fred Grooms was illegally repairing a septic tank system at a mobile home owned 



8:12 NORTH CAROLINA REGISTER September 15, 1993 1177 

Mil ll>^M>Hi i I I 



CONTESTED CASE DECISIONS 



by him. The citizen who complained is in the business of repairing septic tank systems. 

2. Moulton Bailey is an Environmental Health Specialist employed by the Halifax County Health 
Department (hereafter "Halifax"). Over the objection of Petitioner, Bailey was found to be an expert 
in soil science. Bailey inspected Grooms" property on October 14, 1992, and saw Floyd Baugham 
placing gravel in a pit with a backhoe. The pit was approximately three feet deep and located at the 
outlet end of a septic tank. Bailey saw broken terra cotta tile lying broken and scattered in the area 
of the work and saw excavated dirt containing gravel. 

3. Terra cotta tile was, in times past, used to construct nitrification lines leading from septic tanks. For 
several years, and in the present, plastic pipe with holes in it is has been used to construct the lines. 

4. Bailey told Baugham he was repairing a septic tank system without a permit and directed Baugham 
to stop work 

5. On October 15, 1992, Bailey went back to Fred Grooms' property and saw that the pit had been 
covered with dirt. No final inspection had been done or Certificate of Completion issued. 

6. On October 16, 1992, Halifax wrote Petitioner Fred Grooms (hereafter "Grooms") a letter advising 
him that before repairing his septic system. Grooms was required to have a permit. Halifax issued 
a Sewage Violation Notice to Grooms because the work on his septic system had rendered the sewage 
system inoperable. The letter informed Grooms he had fifteen days to secure a permit and repair his 

system or vacate the property. 

7. On October 26,1992, Grooms applied for an Improvement Permit to repair the septic system at his 
house. 

8. Bailey, Jeff Dillard, and Rebecca Edwards met with Grooms on his property on November 12, 1992. 
Dillard was another Environmental Health Specialist and Edwards was Bailey's and Dillard's 
supervisor. The Halifax employees probed the bed system installed by Grooms and augured two 
holes on his property to a depth of forty eight inches. Bailey and Dillard completed a Site/Soil 
Evaluation form with the results of their visit. 

9. The Halifax employees concluded from the existence of broken terra cotta pipe, excavated dirt 
containing gravel and presence of fecal material and toilet tissue on the ground that the previous 
system had failed and had been repaired by Baugham on October 14, 1992. 

10. The failure of the septic tank system which caused fecal material and toilet tissue to be on the ground 
occurred after Baugham's work on October 14, 1992 and before October 26, 1992. The failure was 
the result of plumbing defects between the fixtures in the mobile home and the septic tank. 

11. The Halifax employees concluded from the visit that Grooms had installed a "bed system" for 
treatment of effluent from his house; the dimensions of the system are 8' by 50'(400 sq.ft.); and the 
"bed system" is 3' deep with the bottom foot being filled with gravel. Dillard was received, without 
objection, as an expert in soil science and installation of septic tank systems pursuant to the General 
Statutes and administrative rules covering those systems. 

12. Bailey and Dillard found that Type II soils were present in the hole shown as #1 on Exhibit R7 to a 
depth of 48". Type II soils were present in hole #2 between 24" and 36" below the surface. Type 
III soils were present below 36". Bailey and Dillard concluded from the soils observed in the two 
auger holes that the structure of the soil below 36" was weak and of Type III. 

13. Bed systems such as that installed by Grooms can be permitted if the soil texture can be classified into 
Soil Group I, II, or III. See 15A NCAC 18A .1955(d). The soil texture that is relevant in this case 
is the texture of soil one foot below the bottom of the nitrification trench or bed. See 15A NCAC 18A 



1178 8:12 NORTH CAROLINA REGISTER September 15, 1993 



CONTESTED CASE DECISIONS 



.1955(b). 

14. The mobile home on Grooms' property has two bedrooms. In determining the size a septic tank 
system needs to be to effectively treat sewage, dwelling units have been determined to have a 
minimum volume of 240 gallons per day. 15A NCAC 18A .1949(a). 

15. Type III soils have a long term acceptance rate of sewage of 0.6 - 0.3. 0.3 is the acceptance rate for 
Type III soils with good structure. 0.6 is the acceptance rate for Type III soils with weak structures. 
Bailey and Dillard determined from their observation of soils augured from Grooms' property that 
the structure was weak and that the soil had a long term acceptance rate of 0.5. 

16. Applying these two values Dillard determined that a conventional trench system would need to be 480 
sq. ft. to effectively treat effluent from Grooms' mobile home. (240 gpd divided by 0.5 gpd/sq.ft. 
= 480 sq.ft.). 

17. Therefore, the bed system installed by Grooms would need to be 720 sq. ft. to effectively treat 
effluent. The bed system installed by Grooms is 400 sq. ft. 

18. Halifax wrote Grooms on November 16, 1992 setting forth its conclusions and offering to issue 
Grooms a permit for one of two options: 

a. Increase the existing bed system by 320 sq. ft.; or 

b. Install 213 sq. ft. of trench system (71' long x 3" wide). 

Halifax asked Grooms to notify it by November 24, 1992 which option he chose. 

19. The option of installing the trench system is significantly cheaper than expanding the bed system. 

20. Grooms wrote Halifax a letter dated November 23, 1992 in which he stated his opinion that he had 
not repaired the septic tank system at his property, but had performed maintenance. A permit is not 
required for maintenance of a septic tank system. 

21 . Halifax wrote Grooms on December 1 1 , 1992 taking the position that he had repaired his septic tank 
system without a permit, as a result he had violated the laws and administrative rules governing septic 
tank systems, and that the repair was inadequate to effectively treat sewage from the mobile home on 
his property. 

22. Halifax enclosed a permit allowing Grooms to add a 3' x 71' trench to the existing bed system. The 
system is illustrated on exhibit Rl 1. Grooms has declined to modify the bed system on his property. 

23. Halifax enclosed in its letter of December 11, 1992, a "Second + Final Sewage Violation Notice" 
requiring Grooms to increase the size of the drainfield on the property, pursuant to one of the two 
options by January 15, 1993. 

24. By letter dated January 28, 1993, Halifax forwarded to Grooms the forms to file this contested case. 
Halifax extended to March 31, 1993, the date by which Grooms was required to comply with the 
Second and Final Violation Notice. The letter states, " As of March 31, 1993, if a contested case 
has not been started or if your sewage system has not been properly repaired, we will proceed with 
legal action by swearing out a warrant ...." 

25. On March 11, 1993, Grooms filed the petition commencing this contested case. Halifax has not 
sworn out a warrant against Grooms. 

Based on the foregoing, the undersigned makes the following: 



8:12 NORTH CAROLINA REGISTER September 15, 1993 1179 



CONTESTED CASE DECISIONS 



CONCLUSIONS OF LAW 

1. On or about October 14, 1992, Grooms repaired the septic tank system on his property without a 
permit. 

2. The repaired septic tank system cannot be operated in compliance with Article II of Chapter 130A 
of the North Carolina General Statutes or 15A NCAC 18A .1900 et. seq. 

3. The repair of the septic tank system on Grooms property on or about October 14, 1992 is in violation 
ofG.S. 130A-336. 

4. Halifax has correctly applied the laws and rules governing the installation of septic tank systems in 
concluding that an addition of 213 sq. ft. of trench or 320 sq. ft. of bed system would render the 
repaired septic tank system permittable under the laws and rules governing the installation of septic 
tank systems. 

Based on the foregoing, the undersigned makes the following: 

RECOMMENDED DECISION 

It is recommended that no relief requested by Grooms in his Petition be granted. 

ORDER 

It is hereby ordered that the agency serve a copy of the final decision on the Office of Administrative 
Hearings, P.O. Drawer 27447, Raleigh, N.C. 2761 1-7447, in accordance with North Carolina General Statute 
150B-36(b). 

NOTICE 

The agency making the final decision in this contested case is required to give each party an 
opportunity to file exceptions to this recommended decision and to present written arguments to those in the 
agency who will make the final decision. G.S. 150B-36(a). 

The agency is required by G.S. 150B-36(b) to serve a copy of the final decision on all parties and to 
fiimish a copy to the parties' attorney of record and to the Office of Administrative Hearings. 

The agency that will make the final decision in this contested case is the Secretary of Enviroimient, 
Health and Natural Resources, or his designee. 

This the 26th day of August, 1993. 



Thomas R. West 
Administrative Law Judge 



1180 8:12 NORTH CAROLINA REGISTER September 15, 1993 



NORTH CAROLINA ADMINISTRATIVE CODE CLASSIFICATION SYSTEM 



1 he North Carolina Administrative Code (NCAC) has four major subdivisions of rules. Two of these, 
titles and chapters, are mandatory. The major subdivision of the NCAC is the title. Each major 
department in the North Carolina executive branch of government has been assigned a title number. 
Titles are further broken down into chapters which shall be numerical in order. The other two, 
subchapters and sections are optional subdivisions to be used by agencies when appropriate. 



TITLE/MAJOR DIVISIONS OF THE NORTH CAROLINA ADMINISTRATIVE CODE 
TITLE DEPARTMENT LICENSING BOARDS CHAPTER 



Architecture 2 

Auctioneers 4 

Barber Examiners 6 

Certified Public Accountant Examiners 8 

Chiropractic Examiners 10 

General Contractors 12 

Cosmetic Art Examiners 14 

Dental Examiners 16 

Dietetics/Nutrition 17 

Electrical Contractors 18 

Electrolysis 19 

Foresters 20 

Geologists 21 

Hearing Aid Dealers and Fitters 22 

Landscape Architects 26 

Landscape Contractors 28 

Marital and Family Therapy 31 

Medical Examiners 32 

Midwifery Joint Committee 33 

Mortuary Science 34 

Nursing 36 

Nursing Home Administrators 37 

Occupational Therapists 38 

Opticians 40 

Optometry 42 

Osteopathic Examination & Reg. (Repealed) 44 

Pharmacy 46 

Physical Therapy Examiners 48 
Plumbing, Heating & Fire Sprinkler Contractors 50 

Podiatry Examiners 52 

Practicing Counselors 53 

Practicing Psychologists 54 

Professional Engineers & Land Surveyors 56 

Real Estate Commission 58 

"Reserved" 59 

Refrigeration Examiners 60 

Sanitarian Examiners 62 

Social Work 63 
Speech & Language Pathologists & Audiologists 64 

Veterinary Medical Board 66 



Note: Title 21 contains the chapters of the various occupational licensing boards. 



1 


Administration 


2 


Agriculture 


3 


Auditor 


4 


Economic & Community Development 


5 


Correction 


6 


Council of State 


7 


Cultural Resources 


8 


Elections 


9 


Governor 


10 


Human Resources 


11 


Insurance 


12 


Justice 


13 


Labor 


14A 


Crime Control & Public Safety 


15A 


Environment, Health, and Natural 




Resources 


16 


Public Education 


17 


Revenue 


18 


Secretary of State 


19A 


Transportation 


20 


Treasurer 


*21 


Occupational Licensing Boards 


22 


Administrative Procedures 


23 


Community Colleges 


24 


Independent Agencies 


25 


State Personnel 


26 


Administrative Hearings 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 1181 



CUMULATIVE INDEX 



CUMULATIVE INDEX 

(April 1993 - March 1994) 

Pages Issue 

1 - 92 1 - April 

93 - 228 2 - April 

229 - 331 3 - May 

332 - 400 4 - May 

401 - 455 5 - June 

456 - 502 6 - June 

503 - 640 7 - July 

641 - 708 8 - July 

709 - 792 9 - August 

793 - 875 10 - August 

876 - 1006 11 - September 

1007 - 1184 12 - September 



i 



Unless otherwise identified, page references in this Index are to proposed rules. 



ADMINISTRATION 

Administration's Minimum Criteria, 5 

Low-Level Radioactive Waste Management Authority, 232 

State Employees Combined Campaign, 1008 

ADMINISTRATIVE HEARINGS 

Civil Rights Division, 370 
General, 366 
Rules Division, 367 

AGRICULTURE 

N.C. State Fair, 506 
Plant Industry, 513 
Veterinary Division, 515 

COMMERCE 

Alcoholic Beverage Control Commission, 408, 711 

Banking Commission, 408, 798 

Cemetery Commission, 810 

Savings Institutions Division: Savings Institutions Commission, 461 

State Ports Authority, 811 

ENVIRONMENT, HEALTH, AND NATURAL RESOURCES 

Coastal Management, 279, 571, 962 

Comprehensive Conservation and Management Plan, 882 

Departmental Rules, 465 

Environmental Management, 210, 556, 658, 797, 893 

Health Services, 283, 335, 425, 465, 572, 709, 762, 966, 1098 

Marine Fisheries, 28, 568 

Mining: Mineral Resources, 829 

NPDES Permit, 710 

Soil and Water Conservation, 214 



i 



i 



1182 8:12 NORTH CAROLINA REGISTER September 15, 1993 



CUMULATIVE INDEX 



Wildlife Resources Commission, 32, 663, 831, 965 
Zoological Park, 337 

FEVAL DECISION LETTERS 

Voting Rights Act, 4, 407, 460, 795, 880 

GOVERNOR/LT. GOVERNOR 

Executive Orders, 1, 93, 229, 332, 401, 456, 641, 793, 876, 1007 

HUMAN RESOURCES 

Aging, Division of, 815 

Blind, Services for the, 884 

Deaf and Hard of Hearing, Services for the, 650 

Facility Services, 94, 883, 1014 

Medical Assistance, 25, 414, 553, 712, 888 

Medical Care Commission, 644 

Mental Health, Developmental Disabilities and Substance Abuse Services, 7, 413, 516, 1086 

Social Services Commission, 237, 733, 1091 

INSURANCE 

Actuarial Services, 555, 657 
Financial Evaluation Division, 1093 
Life and Health Division, 1094 
Medical Database Commission, 463, 737 
Special Services Division, 1096 

JUSTICE 

Alarm Systems Licensing Board, 761 

Attorney General, Office of the, 28 

Criminal Justice Education and Training Standards Commission, 253 

Criminal Justice Standards Division, 241 

Departmental Rules, 1096 

Private Protective Services Board, 252, 890 

Sheriffs' Education and Training Standards Commission, 738 

LABOR 

OSHA, 97, 231, 278, 892 

LICENSESfG BOARDS 

Architecture, 43 

Cosmetic Art Examiners, 969 

Dental Examiners, State Board of, 763 

Electrolysis Examiners, Board of, 841 

Foresters, Registration for, 674 

Geologists, Board of, 285 

Medical Examiners, Board of, 591 

Mortuary Science, Board of, 45, 342, 971 

Nursing Home Administrators, 346 

Pharmacy, Board of, 47, 354 

Physical Therapy Examiners, 53, 767 

Plumbing, Heating and Fire Sprinkler Contractors, 360 

Practicing Psychologists, Board of, 844 

Real Estate Commission, 53, 364 

Refrigeration Examiners, 1148 

Social Work, Certification Board for, 428 



8:12 NORTH CAROLINA REGISTER September 15, 1993 1183 



■h ii ^ uf ^^ "- im n — 1 — I 



CUMULATIVE INDEX 



LIST OF RULES CODIFIED 

List of Rules Codified, 61. 290, 432, 593, 769, 845 

PUBLIC EDUCATION 

Elementary and Secondary Education, 427, 470 

STATE PERSONNEL 

Office of State Personnel, 286, 972 

STATE TREASURER 

Retirement Systems, 337, 1146 

TAX REVIEW BOARD 

Orders of Tax Review, 503 

TRANSPORTATION 

Highways, Division of, 669, 836 
Motor Vehicles, Division of, 1145 



1184 



8:12 



NORTH CAROLINA REGISTER 



September 15, 1993 



NORTH CAROLINA ADMINISTRATIVE CODE 



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Treasurer 45.00 
Licensing Boards 75. (X) 
Licensing Boards 75.00 
Licensing Boards 

Administrative Procedures 75.00 
Community Colleges 10.00 
Independent Agencies 10. (X3 
State Personnel 60.00 
Administrative Hearings 10. (X) 

Subtotal 

ina subscribers add 6% sales tax) 

Total 






40 






41 






42 






43 






44 






45 






46 






47 






48 






49 






50 






51 






52 






53 





















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